Microline Pentax, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Microline Pentax, Inc. makes
The company manufactures reusable and disposable laparoscopic surgical instruments, including clip appliers with implantable titanium clips, forceps, scissors, and electrosurgical probes. Their portfolio also includes intraocular surgical tools such as retinal kits and microsissors, as well as specialized laparoscopic accessories like quick-switch instruments and cautery probes.
These devices are classified under FDA regulations as Class I and Class II, with some products requiring 510(k) clearance. The company’s instruments are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Microline Pentax, Inc. have in the registry?
The registry currently lists 12 devices for Microline Pentax, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Microline Pentax, Inc.'s devices?
Among its 12 most recently registered devices, Microline Pentax, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Microline Pentax, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Microline Pentax, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Microline Pentax, Inc. in the registry?
The most recently registered devices listed for Microline Pentax, Inc. include ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS, BRADBURY INTRAOCULAR RETINAL KIT CAT #200, RE-NEW LAPAROSCOPIC INSTRUMENTS and MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10.