REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
FDA 510(k) clearance K926587 · decided 1993-12-17
Clearance details
- K-number
- K926587
- Device name
- REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
- Applicant
- Look, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-01
- Decision date
- 1993-12-17
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ada, OK, 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 |
|---|---|---|
| Tissue Approximation System (K261484) | Tas Medical, Inc. | 2026-06-03 |
| Tissue Approximation System (TAS) (K220980) | Tas Medical, Inc. | 2023-07-05 |
| Golnit Nylon Monofilament Suture (K212888) | Antarma, LLC Dba Golnit Sutures | 2022-03-31 |
| Non Absorbable Surgical Nylon Suture (K212603) | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| Crownjun Nylon Suture (K192420) | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| REXLON, REXSIL (K161633) | Sm Eng Co., Ltd. | 2017-03-02 |
| Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (K151165) | Aesculap, Inc. | 2016-02-17 |
| RiverLon (Nylon) Suture (K152795) | Riverpoint Medical | 2015-10-28 |
| VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (K123034) | Unilene Sac | 2013-05-28 |
| KUMAR T-ANCHORS HERNIA SET (K081366) | Nashville Surgical Instruments | 2008-07-15 |
| FSSB NYLON SURGICAL SUTURES (K060471) | Fssb Chirurgische Nadeln GmbH | 2006-07-26 |
| MANI NEEDLE & SUTURE PACK (NYLON) (K053637) | Mani, Inc. | 2006-05-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S004) | Look, Inc. | 1990-09-12 |
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S002) | Look, Inc. | 1986-06-09 |
| POLYVIOLENE SUTURE (N80950/S003) | Look, Inc. | 1986-06-09 |
| POLYVIOLENE SUTURE (N80950/S002) | Look, Inc. | 1986-02-28 |
| POLYVIOLENE SUTURE (N80950/S001) | Look, Inc. | 1985-03-22 |
| NON-ABSORBABLE BLACK SILK SUTURE (N83074/S001) | Look, Inc. | 1985-03-22 |