STROVER HOOK
FDA 510(k) clearance K841617 · decided 1984-08-27
Clearance details
- K-number
- K841617
- Device name
- STROVER HOOK
- Applicant
- Plastafil, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-19
- Decision date
- 1984-08-27
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- HCF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| Edwards Suture Fastening System (K150882) | Edwards Lifesciences, LLC | 2015-06-16 |
| MICROVASIVE INSURG LAPTIE SUTURE LIGATOR (K931379) | Boston Scientific Corp | 1993-07-13 |
| VALTRAC PURSESTING DEVICE (K851452) | Davis & Geck, Inc. | 1985-06-12 |
| HEMORRHOIDAL LIGATOR (K790577) | J. Sklar Mfg. Co., Inc. | 1979-04-23 |
Recalls involving this device
No recalls on record reference this clearance.