OLYMPUS VIDEO URETEROSCOPE, NTSC— 510(k) K033651
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K033651 for OLYMPUS VIDEO URETEROSCOPE, NTSC, Substantially Equivalent on 2004-01-30. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Melville, NY, US
Recent devices under product code FGB
view all- 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
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K253505 — Zamenix P
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
More clearances from Olympus Winter & Ibe GmbH
view all- K260649 — OES ELITE Cystoscope and Accessories +11 more
- K252043 — Bipolar applicator CelonProBreath (WB990310) +3 more
- K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
- K221522 — HF-cables (resusable)
- K223183 — Light-Guide Cables
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.