Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp)
FDA 510(k) K002190 · Cp Medical
510(k) numberK002190
Submission
- Device name
- Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp)
- Applicant
- Cp Medical
Portland, OR, US - Received
- July 20, 2000
- Decision date
- August 10, 2000
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K173922 | C-PTFETM Surgical SutureNBY · Traditional | 03/26/2018SE |
| K094028 | Cp-Fiber (Orthofiber)GAT · Abbreviated | 03/18/2010SE |
| K072229 | MonoswiftGAM · Abbreviated | 10/05/2007SE |
| K071550 | Pre-Waxed Needles with Gold Fiduciary MarkersKXK · Abbreviated | 07/18/2007SE |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31MTJ · Traditional | 11/02/2006SE |
| K041894 | OrthofiberGAT · Special | 09/17/2004SE |
| K034062 | CP Sleeve and River SleeveKXK · Special | 01/30/2004SE |
| K024372 | CP Medical Bone WaxMTJ · Traditional | 06/19/2003SE |
| K030786 | Mono-SwiftNEW · Abbreviated | 05/06/2003SE |
| K030351 | Stainless Steel Surgical Suture, Non-AbsorbableGAQ · Abbreviated | 03/28/2003SE |
Questions and answers
When was Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp) cleared by the FDA?
Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp) (K002190) received a 510(k) decision of Substantially Equivalent for Some Indications on August 10, 2000, 21 days after the submission was received.
What is the product code of K002190?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.