FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Revolve Surgical System
K Number: K243968
·
Decision Oct 3, 2025
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
1
Review Days
284
Basic Information
- Device Name
- Revolve Surgical System
- K Number
- K243968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Revolve Surgical, Inc.
- Date Received
- December 23, 2024
- Decision Date
- October 3, 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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