Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture
FDA 510(k) K130083 · Demetech Corp.
510(k) numberK130083
Submission
- Device name
- Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture
- Applicant
- Demetech Corp.
Miami Lakes, FL, US - Received
- January 14, 2013
- Decision date
- July 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K201479 | DemeMASKFXX · Abbreviated | 07/24/2020SE |
| K191361 | DemeDIOX Barbed Absorbable Surgical SutureNEW · Traditional | 11/07/2019SE |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical SutureGAT · Traditional | 07/31/2019SE |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical SutureNBY · Traditional | 10/11/2018SE |
| K181582 | DemeTECH DemeDIOX absorbable surgical sutureNEW · Special | 08/27/2018SE |
| K141007 | Demesteel (Stainless Steel) Non-Absorbable SutureGAQ · Traditional | 09/25/2014SE |
| K123940 | Demequicktm (Rapid Absorbable) Synthetic Surgical SutureGAM · Traditional | 05/30/2014SE |
| K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureNEW · Traditional | 01/08/2010SE |
| K072930 | Demetech Absorbable Surgical Suture Plain & Chromic GutGAL · Traditional | 04/30/2008SE |
| K043330 | Polypropilene Surgical SuturesGAW · Traditional | 05/16/2005SE |
Questions and answers
When was Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture cleared by the FDA?
Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (K130083) received a 510(k) decision of Substantially Equivalent on July 17, 2013, 184 days after the submission was received.
What is the product code of K130083?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.