Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture
FDA 510(k) K951352 · Davis & Geck, Inc.
510(k) numberK951352
Submission
- Device name
- Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture
- Applicant
- Davis & Geck, Inc.
Danbury, CT, US - Received
- March 24, 1995
- Decision date
- June 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4493
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 06/25/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | Medtronic | 05/28/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | ETHICON, Inc. | 02/06/2026SE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional | ETHICON, Inc. | 12/22/2025SE |
| K253620 | TroClose 1200GAM · Special | Gordian Surgical, Ltd. | 12/16/2025SE |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special | Internacional Farmacéutica S.A DE C.V | 10/03/2025SE |
| K233265 | Monotime and Optime RGAM · Abbreviated | Peters Surgical | 10/11/2024SE |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated | Peters Surgical | 07/12/2024SE |
| K221527 | StitchKitGAM · Traditional | Origami Surgical Inc . | 02/14/2023SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | ETHICON, Inc. | 11/15/2022SE |
More from ETHICON, Inc.
| 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 Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture cleared by the FDA?
Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture (K951352) received a 510(k) decision of Substantially Equivalent on June 5, 1995, 73 days after the submission was received.
What is the product code of K951352?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.