Product code FAJ— Gastroenterology, Urology
Flexible HD Cysto-Urethroscope System
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 92
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FAJ
- K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,
- K253696 — CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
- K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
- K253905 — PrimeSight UltraView System
- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
- K253226 — UV5000W Handle
- K251140 — Zenflow Spring Scope
- K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- K250797 — UV5000 Handle
- K243653 — KARL STORZ HOPKINS Telescopes for Urology
- K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo
- K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
- K243196 — Uro-G HD Cystoscope (1520)
- K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
- K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance
- K240227 — LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
- K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
- K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
- K232837 — Uro-G HD Flexible Cystoscope
- K231118 — Cystoscope System
- K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
- K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
- K223040 — Endo SmartCap
- K221683 — CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
- K221690 — OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
- K221580 — Single-Use Flexible Cystoscope
- K222162 — Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- K222602 — Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
- K212202 — WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
- K212476 — KARL STORZ Flexible HD Cysto-Urethroscope System
- K210512 — LUMINELLE DTx System
- K202921 — Uro-G Cystoscope
- K202957 — Flexible Video Cysto-Urethroscope (C-view)
- K193095 — Ambu aScope 4 Cysto
- K191357 — Flexible HD Cysto-Urethroscope System
- K182876 — Uro-N Cystoscope
- K182723 — Flexible HD Cysto-Urethroscope System
- K181909 — Luminelle DTx Hysteroscopy System
- K171500 — Uro-V Cystoscope
- K170862 — Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
- K171336 — Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
- K160766 — Ambu USR, Ambu M
- K142194 — CytoSure Urinary Access System
- K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
- K093725 — CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
- K093665 — ENDO SMARTCAP
- K090814 — MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
- K072180 — VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
- K060899 — FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
- K053560 — MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
- K051176 — FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
- K043022 — STRYKER FLEXIBLE CYSTONEPHROSCOPE
- K042780 — NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
- K042225 — ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
- K040215 — VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
- K033191 — SOHNIKS
- K030960 — ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
- K031141 — ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
- K021074 — VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
- K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
- K003988 — UROSCOPE, ARTES MEDICAL, USA
- K003807 — CYSTOSCOPES
- K993041 — OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
- K000197 — CORTEK CYSTOSCOPE
- K993689 — AED CYSTOSCOPE
- K992983 — BAHO AUTOCLAVABLE CYSTOSCOPE
- K992483 — MEDIFIX INC.
- K982620 — MEDIVISION CYSTOSCOPE
- K980401 — FLEXIBLE FIBERSCOPES AND ACCESSORIES
- K980592 — NTECH CYSTOSCOPES
- K970892 — FIEGERT ENDOTECH CYSTOSCOPE
- K964037 — FLEXIBLE CYSTOSCOPE
- K960872 — CYSTOSCOPE 0/15/30/70 DEGREES
- K953201 — IMAGYN UROSCOPE
- K945262 — OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
- K945527 — KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
- K943176 — KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
- K941779 — KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
- K935278 — KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE
- K930827 — BARD STABILIZING CANNULA
- K922320 — OMNI CYSTOSCOPE
- K914008 — PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
- K902274 — CUSTOMED CYSTO PACK I
- K895182 — ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
- K860822 — LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
- K820851 — CURITY ECONOMY II CYSTOSCOPY TRAY
- K760179 — SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR
- K760189 — STOPCOCK, WATERLINE
- K760274 — TIP, RUBBER, PERFORATED
Data sourced from openFDA. This site is unofficial and independent of the FDA.