Revised Labeling for Nylon Suture (Polyamide)
FDA 510(k) K926587 · Look, Inc.
510(k) numberK926587
Submission
- Device name
- Revised Labeling for Nylon Suture (Polyamide)
- Applicant
- Look, Inc.
Ada, OK, US - Received
- December 1, 1992
- Decision date
- December 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAR – Suture, Nonabsorbable, Synthetic, Polyamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5020
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261484 | Tissue Approximation SystemGAR · Special | Tas Medical, Inc. | 06/03/2026SE |
| K220980 | Tissue Approximation System (TAS)GAR · Traditional | Tas Medical, Inc. | 07/05/2023SE |
| K212888 | Golnit Nylon Monofilament SutureGAR · Abbreviated | Antarma, LLC Dba Golnit Sutures | 03/31/2022SE |
| K212603 | Non Absorbable Surgical Nylon SutureGAR · Traditional | Shandong Haidike Medical Product Co., Ltd. | 12/22/2021SE |
| K192420 | Crownjun Nylon SutureGAR · Traditional | Kono Seisakusho Co., Ltd. | 05/29/2020SE |
| K161633 | Rexlon, RexsilGAR · Traditional | Sm Eng Co., Ltd. | 03/02/2017SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 02/17/2016SE |
| K152795 | RiverLon (Nylon) SutureGAR · Special | Riverpoint Medical | 10/28/2015SE |
| K123034 | Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional | Unilene Sac | 05/28/2013SE |
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | Nashville Surgical Instruments | 07/15/2008SE |
More from Nashville Surgical Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K943949 | Polyviolene Surgicl SutureGAT · Traditional | 11/10/1994SN |
| K933686 | Look Inc. 316L Stainless Steel Surgical SutureGAQ · Traditional | 12/23/1993SE |
| K926586 | Revised Labeling for Chromic and Plain Gut SuturesGAL · Traditional | 12/22/1993SE |
| K926588 | Revised Labeling for Polypropylene SutureGAW · Traditional | 12/17/1993SE |
| K926168 | Silk Sutures-Revised LabelingGAR · Traditional | 12/17/1993SE |
| K926167 | Polyviolene Suture-Revised LabelingGAT · Traditional | 12/17/1993SE |
| K913530 | Look ViscodissectorHQC · Traditional | 10/21/1991SE |
| K903029 | Sterile Black Monofilament Nylon Non-Absor. SutureGAR · Traditional | 10/25/1990SE |
| K903584 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | 10/11/1990SE |
| K904054 | Polyviolene(Tm) SutureGAS · Traditional | 10/03/1990SE |
Questions and answers
When was Revised Labeling for Nylon Suture (Polyamide) cleared by the FDA?
Revised Labeling for Nylon Suture (Polyamide) (K926587) received a 510(k) decision of Substantially Equivalent on December 17, 1993, 381 days after the submission was received.
What is the product code of K926587?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.