FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
FDA 510(k) clearance K905440 · decided 1991-01-31
Clearance details
- K-number
- K905440
- Device name
- FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1990-12-04
- Decision date
- 1991-01-31
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- GAS
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene (K203120) | Lsi Solutions, Inc. | 2020-11-24 |
| RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (K203081) | Lsi Solutions | 2020-11-24 |
| ARTHREX BIOWIRE (K091018) | Arthrex, Inc. | 2010-07-30 |
| MR-III (K002261) | Smith & Nephew, Inc. | 2000-10-23 |
| SUTURE CORD (K953128) | Phoenix Biomedical Corp. | 1996-02-09 |
| BRAIDED POLYESTER SUTURE MATERIAL (K923161) | Mitek Surgical Products, Inc. | 1992-12-30 |
| PETERS CARDIOFLON(TM) SUTURE (K913101) | Promedica Products, Inc. | 1992-08-12 |
| MITEK QUICKANCHOR(TM), MODIFICATION (K915089) | Mitek Surgical Products, Inc. | 1992-02-03 |
| MITEK SNAP PAK(TM), MODIFICATION (K915081) | Mitek Surgical Products, Inc. | 1992-01-31 |
| ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (K903175) | Advance Suture, Inc. | 1991-07-26 |
| IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (K905285) | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 |
| LU-TEX II (K904535) | Lukens Medical Corp. | 1991-01-30 |
Recalls involving this device
No recalls on record reference this clearance.