Percuvision, LLC
United StatesFDA applicant, unverified
Percuvision, LLC is a medical device manufacturer, with 8 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 15 Nov 2026.
- Devices
- 8
Registry facts
- Registries
- FDA GUDID 5
- FDA 510(k) 3
- Device classes
- FDA Class II 7
- Identifiers
- DUNS 015755434
What Percuvision, LLC makes
Percuvision, LLC manufactures reusable flexible video cystoscopes for diagnostic and procedural use in urological examinations. Their product line includes indwelling urethral drainage balloon catheters and adult catheterization kits, designed for urinary drainage applications. The DirectVision series encompasses cystoscopes, guide systems, and related accessories for minimally invasive procedures.
The company’s devices are classified under FDA Class II regulations, with authorisations recorded via 510(k) and UDI submissions. Products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. Percuvision, LLC operates from the United States.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Percucath Urinary Catheter Ref K090262
Regimes: 510(k) Registry: 510(k)Directvision Catheter, Uncoated Ref K110214
Regimes: 510(k) Registry: 510(k)Directvision Guide System Ref K091600
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 015755434
Frequently asked questions
How many devices does Percuvision, LLC have in the registry?
The registry currently lists 8 devices for Percuvision, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Percuvision, LLC's devices?
Among its 8 most recently registered devices, Percuvision, LLC has devices listed in FDA 510(k) (3 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Percuvision, LLC's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Percuvision, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Percuvision, LLC in the registry?
The most recently registered devices listed for Percuvision, LLC include DirectVision MA100282, DirectVision MA100143, DirectVision MA100288 and DirectVision MA100180.