'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture
FDA 510(k) K001434 · Genzyme Surgical Product (Genzyme Biosurgery)
510(k) numberK001434
Submission
- Device name
- 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
Fall River, MA, US - Received
- May 8, 2000
- Decision date
- June 12, 2000
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K001440 | Nextstitch Cardiovascular Valve SutureGAT · Traditional | 11/13/2000SE |
| K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 09/03/1999SE |
| K991416 | Endoscopic CameraGCJ · Traditional | 07/20/1999SE |
| K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 06/22/1999SE |
| K990062 | SaphliftMDM · Traditional | 03/30/1999SE |
| K982712 | Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250CAC · Traditional | 12/18/1998SE |
| K980016 | Millennium Valve Introducer/Rotator HandleMOP · Traditional | 08/07/1998SE |
| K981322 | Cutalon Nylon Polyamide Surgical SutureGAR · Traditional | 07/07/1998SE |
Questions and answers
When was 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture cleared by the FDA?
'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture (K001434) received a 510(k) decision of Substantially Equivalent for Some Indications on June 12, 2000, 35 days after the submission was received.
What is the product code of K001434?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.