510(k) clearances

Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

Momentis Surgical , Ltd. · General, Plastic Surgery

K251056Substantially EquivalentSpecialQNM
Open FDA's page for this record
Third party flag
N
City
Or Yehuda
Advisory committee description
General, Plastic Surgery
Address 1
6 Yoni Netanyahu St.
Statement or summary
Summary
Product code
QNM
Zip code
6037604
Applicant
Momentis Surgical , Ltd.
Decision date
2025-05-02
Decision code
SESE
Country code
IL
Device name
Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
Advisory committee
SU
Contact
Maya Leib Shlomo
K number
K251056
Date received
2025-04-04
Review advisory committee
SU
Postal code
6037604
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Mountable Electromechanical Surgical System For Transluminal Approaches
Medical specialty description
General, Plastic Surgery
Regulation number
878.4961
Device class
2
Registration number
3008729892, 3014155960, 3003623887
FEI number
3014155960, 3003623887, 3002807555
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.