Polyester Nonabsorbable Surgical Sutures Usp
FDA 510(k) K961925 · R. K. Medical L. L. C.
510(k) numberK961925
Submission
- Device name
- Polyester Nonabsorbable Surgical Sutures Usp
- Applicant
- R. K. Medical L. L. C.
Mahwah, NJ, US - Received
- May 17, 1996
- Decision date
- July 29, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K961931 | Plain Gut & Chronic Gut Absorbable Surgical Sutures UspGAL · Traditional | 07/29/1996SE |
| K961389 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | 06/18/1996SN |
| K960328 | Silk Nonabsorbable Surgical Sutures UspGAP · Traditional | 03/04/1996SN |
| K960327 | Nylon Noabsorbable Surgical Sutures UspGAR · Traditional | 03/04/1996SN |
Questions and answers
When was Polyester Nonabsorbable Surgical Sutures Usp cleared by the FDA?
Polyester Nonabsorbable Surgical Sutures Usp (K961925) received a 510(k) decision of Substantially Equivalent for Some Indications on July 29, 1996, 73 days after the submission was received.
What is the product code of K961925?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.