Surgibond
FDA 510(k) K943221 · Sutures , Ltd.
510(k) numberK943221
Submission
- Device name
- Surgibond
- Applicant
- Sutures , Ltd.
Ruabon, Wrexham, GB - Received
- July 5, 1994
- Decision date
- December 5, 1994
- 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 |
|---|---|---|
| K990432 | SurgisorbGAM · Traditional | 05/27/1999SN |
| 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 |
| 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 Surgibond cleared by the FDA?
Surgibond (K943221) received a 510(k) decision of Substantially Equivalent for Some Indications on December 5, 1994, 153 days after the submission was received.
What is the product code of K943221?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.