ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
FDA 510(k) clearance K881224 · decided 1988-06-01
Clearance details
- K-number
- K881224
- Device name
- ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
- Applicant
- Acufex Microsurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-22
- Decision date
- 1988-06-01
- Days to decision
- 71 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
- Norwood, 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 |
| ACUFEX SUTURE RETRIEVER (K926036) | Acufex Microsurgical, Inc. | 1993-05-05 |
| ADVANCE SUTURE ABSORBABLE GUT SUTURE (K903174) | Advance Suture, Inc. | 1991-07-10 |
Recalls involving this device
No recalls on record reference this clearance.