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.
Summary
Momentis Surgical's Anovo Surgical System (6Ne) is filed under SCV, modular electromechanical surgical systems. The record doesn't list the system's components or instruments.
Class II, 21 CFR 878.4964. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Momentis Surgical filed from Or Yehuda, Israel. Review took 132 calendar days (March 12 to July 22, 2026).
Clearance details
- Applicant
- Momentis Surgical , Ltd.
- Product code
- Product 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.