Silk Suture
FDA 510(k) K982853 · Davis & Geck, Inc.
510(k) numberK982853
Submission
- Device name
- Silk Suture
- Applicant
- Davis & Geck, Inc.
Hazlewood, MO, US - Received
- August 13, 1998
- Decision date
- April 30, 1999
- 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 |
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| K980062 | Monojectt Bluntip I.V. Access Cannula with Vial Access Pin DeviceFMI · Traditional | 03/20/1998SE |
| K973409 | Kangaroo Enteral Feeding Extension Set for Syringe PumpsKNT · Traditional | 02/27/1998SE |
| K970857 | Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle…CAC · Traditional | 11/05/1997SE |
| K972139 | Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope…BTM · Traditional | 09/03/1997SE |
| K972566 | Dexon VioletGAM · Traditional | 08/14/1997SE |
| K962971 | Polypropylene Mesh (Various Sizes)FTL · Traditional | 09/16/1996SE |
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Questions and answers
When was Silk Suture cleared by the FDA?
Silk Suture (K982853) received a 510(k) decision of Substantially Equivalent for Some Indications on April 30, 1999, 260 days after the submission was received.
What is the product code of K982853?
The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.