American Cystocope Makers, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What American Cystocope Makers, Inc. makes
American Cystocope Makers, Inc. manufactures flexible and rigid endoscopes for diagnostic and therapeutic procedures, including nephroscopes, duodenoscopes, and panendoscopes. Their portfolio also includes hemostatic electrodes, aspirator kits, sterile fluid-producing units, and accessory devices like air-water sources for endoscopic use.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These endoscopy-related instruments are listed in the FDA’s 510(k) database, reflecting their authorised status in the United States.
Catalogue
Acmi Rigi-Flex Nephorscope Ref K791182
Regimes: 510(k) Registry: 510(k)Colonoscope, 2-Channel Log (Acmi Tx-92) Ref K760452
Regimes: 510(k) Registry: 510(k)Acmi Bipolar Hemostatic Electrode Ref K803214
Regimes: 510(k) Registry: 510(k)Duodenoscope, Molel Tx-6 Ref K770754
Regimes: 510(k) Registry: 510(k)Acmi Aspirator Kit #8808 Ref K811218
Regimes: 510(k) Registry: 510(k)Model Tx-8 Panendoscope Ref K760822
Regimes: 510(k) Registry: 510(k)Sterile Fluid Producing Unit #EP550 Ref K832040
Regimes: 510(k) Registry: 510(k)Acmi Bipolar Hemostatic Source Ref K812637
Regimes: 510(k) Registry: 510(k)Air Water Source (Acmi Model 710) Ref K760451
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Cystocope Makers, Inc. have in the registry?
The registry currently lists 9 devices for American Cystocope Makers, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Cystocope Makers, Inc.'s devices?
Among its 9 most recently registered devices, American Cystocope Makers, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do American Cystocope Makers, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for American Cystocope Makers, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Cystocope Makers, Inc. in the registry?
The most recently registered devices listed for American Cystocope Makers, Inc. include ACMI RIGI-FLEX NEPHORSCOPE, COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92), ACMI BIPOLAR HEMOSTATIC ELECTRODE and DUODENOSCOPE, MOLEL TX-6.