Nexus Suture
FDA 510(k) clearance K151009 · decided 2015-08-18
Clearance details
- K-number
- K151009
- Device name
- Nexus Suture
- Applicant
- Baylis Medical Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-15
- Decision date
- 2015-08-18
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- GAT
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EasyWhip Family (K261021) | Winter Innovations, Inc. | 2026-07-01 |
| Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775) | Teleflex Medical, LLC | 2026-05-06 |
| HyperSuture All Green Extension Line (K254275) | Threadstone, LLC | 2026-03-23 |
| Meniscus Versaflex (K254188) | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| Pre-Sutured Tendon (K253145) | Rti Surgical, Inc. | 2025-10-22 |
| ProZip Knotless Implant (K253024) | Riverpoint Medical | 2025-10-16 |
| PowerKnot High Strength Sutures (K252225) | Medacta International S.A. | 2025-09-12 |
| HS Fiber (K252201) | Riverpoint Medical | 2025-08-13 |
| HyperSuture White/Green Extension Line (K242201) | Threadstone, LLC | 2025-03-27 |
| HyperSuture All Blue Extension Line (K241376) | Threadstone, LLC | 2024-08-09 |
| HyperSuture Extension Line (K234079) | Threadstone, LLC | 2024-05-10 |
| HS Fiber Sutures (K231163) | Riverpoint Medical | 2024-01-05 |
Recalls involving this device
No recalls on record reference this clearance.