Anchor Band Suturing System, Model Sr-Ab
FDA 510(k) K061386 · Anulex Technologies, Inc.
510(k) numberK061386
Submission
- Device name
- Anchor Band Suturing System, Model Sr-Ab
- Applicant
- Anulex Technologies, Inc.
Minnetonka, MN, US - Received
- May 18, 2006
- Decision date
- July 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K121356 | Micro/Mini N-Pk(H) Bone AnchorMBI · Traditional | 11/09/2012SE |
| K121354 | Micro/Mini N-Pk(F) Bone AnchorMBI · Traditional | 11/09/2012SE |
| K113805 | Fixate Tissue BandGZB · Traditional | 02/23/2012SE |
| K113400 | Fixate Tissue BandGZB · Special | 12/16/2011SE |
| K112849 | Fixate Tissue BandGZB · Special | 10/27/2011SE |
| K111462 | Fixate Tissue BandGZB · Traditional | 09/08/2011SE |
| K100572 | Versaclose, Model VC-200-01GAT · Special | 03/17/2010SE |
| K091432 | Xclose Tissue Repair System, Model XC-200-01GAT · Special | 06/12/2009SE |
| K082729 | Rimclose Bone AnchorMBI · Traditional | 12/19/2008SE |
| K062307 | Xclose Tissue Repair System, Model SRSGAT · Special | 09/01/2006SE |
Questions and answers
When was Anchor Band Suturing System, Model Sr-Ab cleared by the FDA?
Anchor Band Suturing System, Model Sr-Ab (K061386) received a 510(k) decision of Substantially Equivalent on July 5, 2006, 48 days after the submission was received.
What is the product code of K061386?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.