Expanded Body Suture
FDA 510(k) K961025 · Medicinelodge, Inc.
510(k) numberK961025
Submission
- Device name
- Expanded Body Suture
- Applicant
- Medicinelodge, Inc.
Sacramento, CA, US - Received
- March 14, 1996
- Decision date
- April 15, 1996
- 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 |
|---|---|---|
| K072525 | Zipknot, Model 1017-3000FZP · Special | 10/05/2007SE |
| K051488 | Medicinelodge ZipknotNVH · Traditional | 07/27/2005SE |
| K962705 | Mli Modular StapleJDR · Traditional | 10/01/1996SE |
| K961920 | Cross PinJDW · Traditional | 09/17/1996SE |
| K961905 | Medicinelodge, Inc. Set ScrewHWC · Traditional | 08/06/1996SE |
| K962194 | Mli Soft Tissue Screw & Washer SystemMBI · Traditional | 07/30/1996SE |
| K953350 | Mli Interference ScrewHWC · Traditional | 01/30/1996SN |
Questions and answers
When was Expanded Body Suture cleared by the FDA?
Expanded Body Suture (K961025) received a 510(k) decision of Substantially Equivalent for Some Indications on April 15, 1996, 32 days after the submission was received.
What is the product code of K961025?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.