510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242157Substantially Equivalent

Anovo Surgical System (Model 6Ne)

Momentis Surgical Ltd., Or Yehuda, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242157 is the FDA 510(k) clearance record for Anovo Surgical System (Model 6Ne), a class II device, cleared for Momentis Surgical , Ltd. on under FDA product code QNM (Mountable Electromechanical Surgical System For Transluminal Approaches). FDA's definition for product code QNM reads: "A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to...". FDA records list 9 510(k) clearances for Momentis Surgical , Ltd., from to . As of , FDA records show no recalls naming K242157.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QNM Mountable Electromechanical Surgical System For Transluminal Approaches
Regulation
21 CFR 878.4961
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Momentis Surgical , Ltd. 6 Yoni Netanyahu St., Or Yehuda, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNM

Trailing 12 months

FDA records hold no clearances under product code QNM in the trailing twelve months.

FDA records show no clearances under product code QNM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260