MCCULLEY CONTINUOUS SUTURE TIGHTNER
FDA 510(k) clearance K801608 · decided 1980-08-12
Clearance details
- K-number
- K801608
- Device name
- MCCULLEY CONTINUOUS SUTURE TIGHTNER
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-15
- Decision date
- 1980-08-12
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HND
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, 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 |
|---|---|---|
| THORNTON TITANIUM SILVER SPATULA (K863990) | Keeler Instruments, Inc. | 1986-10-31 |
| ANIS IRRIGATING SPATULA (K810937) | American V. Mueller | 1981-05-15 |
| MADDOX LENS SPATULA CAT. #7245 (K801609) | Edward Weck, Inc. | 1980-08-13 |
| SPATULA'S #'S 7618,7248,7240,7242,5108 (K791983) | Edward Weck, Inc. | 1979-10-04 |
| CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM (K761253) | Edward Weck, Inc. | 1976-12-16 |
Recalls involving this device
No recalls on record reference this clearance.