Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures
FDA 510(k) K091574 · Supplidores Unidos Internacionales, S.A.
510(k) numberK091574
Submission
- Device name
- Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures
- Applicant
- Supplidores Unidos Internacionales, S.A.
Coconut Creek, FL, US - Received
- June 2, 2009
- Decision date
- October 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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 |
Questions and answers
When was Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures cleared by the FDA?
Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures (K091574) received a 510(k) decision of Substantially Equivalent on October 9, 2009, 129 days after the submission was received.
What is the product code of K091574?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.