Surgilene Polypropylene Suture
FDA 510(k) K930587 · Davis & Geck, Inc.
510(k) numberK930587
Submission
- Device name
- Surgilene Polypropylene Suture
- Applicant
- Davis & Geck, Inc.
Danbury, CT, US - Received
- February 4, 1993
- Decision date
- December 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
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| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982853 | Silk SutureGAP · Traditional | 04/30/1999SN |
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| K980610 | Dexon Rapid (Dexon R)GAM · Traditional | 05/18/1998SE |
| K974015 | Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick-…FOZ · Traditional | 05/18/1998SE |
| 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 |
Questions and answers
When was Surgilene Polypropylene Suture cleared by the FDA?
Surgilene Polypropylene Suture (K930587) received a 510(k) decision of Substantially Equivalent on December 17, 1993, 316 days after the submission was received.
What is the product code of K930587?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.