CHERRY SPONGE
FDA 510(k) clearance K913500 · decided 1991-09-25
Clearance details
- K-number
- K913500
- Device name
- CHERRY SPONGE
- Applicant
- O.R. Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-07
- Decision date
- 1991-09-25
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch O.R. Concepts
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 |
|---|---|---|
| Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection o recall (Z-2221-2024) | ASPEN SURGICAL | 2024-06-27 |