OPTICAL FORCEPS
FDA 510(k) clearance K990561 · decided 1999-05-14
Clearance details
- K-number
- K990561
- Device name
- OPTICAL FORCEPS
- Applicant
- Pilling Weck Surgical
- Decision
- Substantially Equivalent
- Date received
- 1999-02-22
- Decision date
- 1999-05-14
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- JEK
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Fort Washington, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MALLEUS NIPPERS (K822198) | Kelleher Corp. | 1982-08-25 |
| FORCEPS FOR USE WITH RIGID ENDOSCOPES (K822193) | Kelleher Corp. | 1982-08-24 |
Recalls involving this device
No recalls on record reference this clearance.