Nylon Noabsorbable Surgical Sutures Usp
FDA 510(k) K960327 · R. K. Medical L. L. C.
510(k) numberK960327
Submission
- Device name
- Nylon Noabsorbable Surgical Sutures Usp
- Applicant
- R. K. Medical L. L. C.
Mahwah, NJ, US - Received
- January 24, 1996
- Decision date
- March 4, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K961931 | Plain Gut & Chronic Gut Absorbable Surgical Sutures UspGAL · Traditional | 07/29/1996SE |
| K961925 | Polyester Nonabsorbable Surgical Sutures UspGAT · Traditional | 07/29/1996SN |
| K961389 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | 06/18/1996SN |
| K960328 | Silk Nonabsorbable Surgical Sutures UspGAP · Traditional | 03/04/1996SN |
Questions and answers
When was Nylon Noabsorbable Surgical Sutures Usp cleared by the FDA?
Nylon Noabsorbable Surgical Sutures Usp (K960327) received a 510(k) decision of Substantially Equivalent for Some Indications on March 4, 1996, 40 days after the submission was received.
What is the product code of K960327?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.