CHF-B20 CHOLEDOCHOSCOPE
FDA 510(k) clearance K904799 · decided 1991-03-27
Clearance details
- K-number
- K904799
- Device name
- CHF-B20 CHOLEDOCHOSCOPE
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-24
- Decision date
- 1991-03-27
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. recall (Z-0330-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |