FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex Synergy Vision Imaging System
K Number: K251994
·
Decision Oct 16, 2025
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
348
Review Days
111
Basic Information
- Device Name
- Arthrex Synergy Vision Imaging System
- K Number
- K251994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex, Inc.
- Date Received
- June 27, 2025
- Decision Date
- October 16, 2025
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Arthrex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | May 28, 2026 | Substantially Equivalent |
| K254215 | Arthrex Beaming System | May 8, 2026 | Substantially Equivalent |
| K252016 | Arthrex Humeral Nails | Mar 20, 2026 | Substantially Equivalent |
| K260561 | Arthrex FiberTak Suture Anchor | Mar 20, 2026 | Substantially Equivalent |
| K260405 | FiberTape Button | Mar 9, 2026 | Substantially Equivalent |
| K252196 | Arthrex FibuLock Nail System | Mar 5, 2026 | Substantially Equivalent |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Mar 3, 2026 | Substantially Equivalent |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Mar 2, 2026 | Substantially Equivalent |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Jan 21, 2026 | Substantially Equivalent |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Jan 12, 2026 | Substantially Equivalent |