ACUFEX SUTURE RETRIEVER
FDA 510(k) clearance K926036 · decided 1993-05-05
Clearance details
- K-number
- K926036
- Device name
- ACUFEX SUTURE RETRIEVER
- Applicant
- Acufex Microsurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-01
- Decision date
- 1993-05-05
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- GAE
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mansfield, MA, 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 |
|---|---|---|
| BIPOLAR SNARE (K950776) | Cook Urological, Inc. | 1995-04-18 |
| ADVANCE SUTURE ABSORBABLE GUT SUTURE (K903174) | Advance Suture, Inc. | 1991-07-10 |
| ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE (K881224) | Acufex Microsurgical, Inc. | 1988-06-01 |
Recalls involving this device
No recalls on record reference this clearance.