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Data / Medical devices / Modular Electromechanical Surgical System

Modular Electromechanical Surgical System (SCV): 15 FDA-registered makers in 7 countries

15 establishments in 7 countries are registered with the FDA to make Modular Electromechanical Surgical System (product code SCV, Class 2, 21 CFR 878.4964). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on October 21, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
SCV
Device class
2
Regulation
878.4964
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States6
United Kingdom2
Dominican Republic2
Germany2
Israel1
Mexico1
Ireland1

Makers of Modular Electromechanical Surgical System

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CMR Surgical LimitedCambridge Cambridgeshire, United KingdomManufacturer, Specification developer1December 16, 2025010api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer1December 3, 2025000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer1December 3, 2025000api.fda.gov
Das Medical International, SRLLa Romana, Dominican RepublicManufacturer1December 3, 2025000api.fda.gov
Momentis Surgical Ltd.Or Yehuda Tel Aviv, IsraelComplaint file establishment, Manufacturer1July 22, 2026000api.fda.gov
Amphenol Alden Products CompanyHermosillo Sonora, MexicoContract manufacturer0000api.fda.gov
Bowa-Electronic GMBHGOMARINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Clinical Polymer Technologies LtdCoalville Leicestershire, United KingdomContract manufacturer0000api.fda.gov
CovidienBoulder, CO, United StatesManufacturer0000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer0000api.fda.gov
Micro Stamping CorporationSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
PMC SMART Solutions, LLCShelbyville, IN, United StatesContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SchivoWaterford Waterford(City And County), IrelandContract manufacturer0000api.fda.gov

Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.