Surgisorb
FDA 510(k) K990432 · Sutures , Ltd.
510(k) numberK990432
Submission
- Device name
- Surgisorb
- Applicant
- Sutures , Ltd.
Ruabon, Wrexham, GB - Received
- February 11, 1999
- Decision date
- May 27, 1999
- 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 |
|---|---|---|
| K953609 | ProdekGAW · Traditional | 01/31/1996SN |
| K943627 | SurgisilkGAP · Traditional | 12/05/1994SN |
| K943223 | Surgidek BGAR · Traditional | 12/05/1994SN |
| K943222 | Surgidek SGAR · Traditional | 12/05/1994SN |
| K943221 | SurgibondGAT · Traditional | 12/05/1994SN |
| K943220 | SutuleneGAT · Traditional | 12/05/1994SN |
| K943218 | Chromic CatgutGAL · Traditional | 12/05/1994SN |
| K943217 | Plain CatgutGAL · Traditional | 12/05/1994SN |
| K943216 | SurgidekGAR · Traditional | 12/05/1994SN |
| K865038 | SurgisteelGAQ · Traditional | 06/30/1987SE |
Questions and answers
When was Surgisorb cleared by the FDA?
Surgisorb (K990432) received a 510(k) decision of Substantially Equivalent for Some Indications on May 27, 1999, 105 days after the submission was received.
What is the product code of K990432?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.