Flexible Video Cysto-Urethroscope (C-view)— 510(k) K202957
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K202957 for Flexible Video Cysto-Urethroscope (C-view), Substantially Equivalent on 2020-10-29. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- El Segundo, CA, US
Recent devices under product code FAJ
view all- K260649 — OES ELITE Cystoscope and Accessories +11 more
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- K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more
- K253905 — PrimeSight UltraView System
- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
More clearances from KARL STORZ Endoscopy-America, Inc.
view allAdverse 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 →
Recalls naming K202957
K-number listed on FDA's recall record- Z-1234-2022 — STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
- Z-1065-2022 — 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202957.
Data sourced from openFDA. This site is unofficial and independent of the FDA.