GI Windows Flexagon Plus OTOLoc System— 510(k) K261630
Substantially EquivalentGI Windows Surgical
FDA 510(k) clearance K261630 for GI Windows Flexagon Plus OTOLoc System, Substantially Equivalent on 2026-10-28. Applicant: GI Windows Surgical. Device class: 2.
Clearance details
- Applicant
- GI Windows Surgical
- Product code
- Product code SAH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4816
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Canton, MA, US
Recent devices under product code SAH
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