Ti-Cron and Dacron Sutures
FDA 510(k) K930591 · Davis & Geck, Inc.
510(k) numberK930591
Submission
- Device name
- Ti-Cron and Dacron Sutures
- 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
- 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 |
|---|---|---|
| K982853 | Silk SutureGAP · Traditional | 04/30/1999SN |
| K981582 | Surgilon, Dermalon, & OphthalonGAR · Traditional | 07/13/1998SE |
| 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 Ti-Cron and Dacron Sutures cleared by the FDA?
Ti-Cron and Dacron Sutures (K930591) 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 K930591?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.