FLEXIBLE URETEROSCOPE— 510(k) K964482
Substantially EquivalentApplied Fiberoptics, Inc.
FDA 510(k) clearance K964482 for FLEXIBLE URETEROSCOPE, Substantially Equivalent on 1997-01-24. Applicant: Applied Fiberoptics, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Fiberoptics, Inc.
- 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
- Traditional
- Location
- Southbridge, MA, 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 Applied Fiberoptics, Inc.
view allAdverse 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.