FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253— 510(k) K991178
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K991178 for FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253, Substantially Equivalent on 1999-06-11. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Product code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Recent devices under product code FGB
view all- K262437 — Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
- K260708 — Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection) +1 more
- K261447 — CVAC® Aspiration System
- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
More clearances from Richard Wolf Medical Instruments Corp.
view all- K151282 — core nova Complete Operating Room Endoscopy
- K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
- K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
- K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.