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

Or Yehuda Tel Aviv, IL

Momentis Surgical Ltd. appears in FDA device records in Or Yehuda Tel Aviv, IL. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Momentis Surgical Ltd. between 2021 and 2026. The busiest year on record is 2025, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Momentis Surgical Ltd., by decision year
YearClearances
20211
20231
20242
20254
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260804Anovo Surgical System (6Ne)SCVSubstantially Equivalent
K251761Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeQNMSubstantially Equivalent
K250591Anovo Surgical System (6Ne)QNMSubstantially Equivalent
K251056Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeQNMSubstantially Equivalent
K243182Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook ElectrodeQNMSubstantially Equivalent
K242157Anovo Surgical System (Model 6Ne)QNMSubstantially Equivalent
K241907Anovo Surgical System (model 6N)QNMSubstantially Equivalent
K232146Anovo PedestalQNMSubstantially Equivalent
DEN190022Hominis Surgical SystemQNMUnknown

Registered establishments

FDA registered establishments for Momentis Surgical Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30141559603014155960Momentis Surgical Ltd.6 Yoni Netanyahu, Or Yehuda Tel Aviv 6037604 IL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain