RING HANDLE & RETRACTORS
FDA 510(k) clearance K772381 · decided 1978-01-17
Clearance details
- K-number
- K772381
- Device name
- RING HANDLE & RETRACTORS
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-27
- Decision date
- 1978-01-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KAL
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edward Weck
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.
| Record | Firm | Date |
|---|---|---|
| SMALL MASTOID RETRACTOR (K870758) | Treace Medical, Inc. | 1987-03-04 |
| ADJUSTABLE FORK RETRACTOR (K833604) | Microtek Medical, Inc. | 1984-01-03 |
| ALLPORT MASTOID RETRACTORS (K772392) | Edward Weck, Inc. | 1978-01-17 |
| CONVERSE ALTAR RETRACTOR (K760851) | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 |
Recalls involving this device
No recalls on record reference this clearance.