Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical Sutures
FDA 510(k) K072863 · Internacional Farmaceutica, S.A. DE C.V.
510(k) numberK072863
Submission
- Device name
- Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical Sutures
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
Great Neck, NY, US - Received
- October 5, 2007
- Decision date
- May 23, 2008
- 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 |
|---|---|---|
| K072859 | Atramat PGLA90 Poly(Glycolide-Co-L-Lactide) Surgical SuturesGAM · Traditional | 05/23/2008SE |
| K041048 | Polydioxanone Synthetic Absorbable Surgical SutureNEW · Traditional | 06/04/2004SE |
| K040282 | Atramat and Sorb-Fast Polyglycolic AcidGAM · Traditional | 04/29/2004SE |
| K913185 | Sterile Stainless Steel Monofil Nonabsorb Surg SutGAQ · Traditional | 12/04/1991SE |
| K911354 | Sterile Plain Gut/Chromic Gut Absorb Surg SuturesGAL · Traditional | 10/25/1991SE |
| K911189 | Sterile Polypropylene Monfil Nonabsorb Surg SutureGAW · Traditional | 04/25/1991SE |
| K905287 | Ifsa Sterile Silk Braided Nonabsor Surg SuturesGAP · Traditional | 02/11/1991SE |
| K905286 | Ifsa Sterile Nlylon Monofil Nonabsor Surg SuturesGAR · Traditional | 02/11/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | 02/11/1991SE |
Questions and answers
When was Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical Sutures cleared by the FDA?
Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical Sutures (K072863) received a 510(k) decision of Substantially Equivalent on May 23, 2008, 231 days after the submission was received.
What is the product code of K072863?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.