Anovo Surgical System (6Ne)— 510(k) K260804
Substantially EquivalentMomentis Surgical , Ltd.
FDA 510(k) clearance K260804 for Anovo Surgical System (6Ne), Substantially Equivalent on 2026-07-22. Applicant: Momentis Surgical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Momentis Surgical , Ltd.
- Product code
- Code SCV
- Device class
- Class 2
- Regulation
- 21 CFR 878.4964
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Or Yehuda, IL
Recent devices under product code SCV
view allMore clearances from Momentis Surgical , Ltd.
view all- K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
- K250591 — Anovo Surgical System (6Ne)
- K251056 — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
- K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
- K242157 — Anovo Surgical System (Model 6Ne)
Adverse events under product code SCV
product code SCV- Malfunction
- 608
- Total
- 608
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.