Silk Nonabsorbable Surgical Sutures Usp
FDA 510(k) K960328 · R. K. Medical L. L. C.
510(k) numberK960328
Submission
- Device name
- Silk Nonabsorbable 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
- GAP – Suture, Nonabsorbable, Silk
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5030
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | Covidien | 12/03/2024SE |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…GAP · Traditional | Safepath Medical, Inc. | 10/18/2024SE |
| K232355 | Non absorbable Surgical Silk SutureGAP · Traditional | Shandong Haidike Medical Product Co., Ltd. | 01/16/2024SE |
| K221767 | Surgical Sutures with or without NeedleGAP · Traditional | Huaian Seamen Medical Technology Co., Ltd. | 07/31/2023SE |
| K180701 | SafePath Suturing SystemGAP · Traditional | Safepath Medical, Inc. | 06/25/2018SE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special | M/s. Meril Endo Surgery Private Limited. | 10/20/2017SE |
| K162396 | SILK Surgical SutureGAP · Traditional | Teleflexmedical, Inc. | 11/23/2016SE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional | M/s. Meril Endo Surgery Private Limited. | 05/31/2016SE |
| K080684 | Wg-Surgical Sutures with NeedleGAP · Traditional | Foosin Medical Supplies, Inc. | 06/09/2008SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | Arrow Intl., Inc. | 07/17/2007SE |
More from Arrow Intl., Inc.
| 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 |
| K960327 | Nylon Noabsorbable Surgical Sutures UspGAR · Traditional | 03/04/1996SN |
Questions and answers
When was Silk Nonabsorbable Surgical Sutures Usp cleared by the FDA?
Silk Nonabsorbable Surgical Sutures Usp (K960328) 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 K960328?
The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.