DirectVision MA100288

by Percuvision, LLC

DirectVision MA100288 is a flexible video cystoscope (FDA Class II; FDA product code FGC, Urethroscope) made by Percuvision, LLC, cleared under FDA 510(k) K091600 on 25 Aug 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00855308006021), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00855308006021 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK091600	Date25 Aug 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00855308006021
FDA 510(k) database 510(k) number K091600

Across registries

2 registries list this device

FDA 510(k) K091600 decided 25 Aug 2009 Active
FDA GUDID UDI-DI 00855308006021 listed 23 Sep 2016 Listed

Timeline

2 dated events

25 Aug 2009 Cleared FDA 510(k) K091600
23 Sep 2016 Listed FDA GUDID 00855308006021

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: DirectVision
Generic name: Flexible video cystoscope, reusable
Model / reference: MA100288

Primary DI / UDI-DI: 00855308006021
510(k) Number: K091600
FDA product code: FGC
GMDN term: Flexible video cystoscope, reusable

Device class: Class II
Regulation number: 876.1500
GUDID distribution status: In Commercial Distribution

Other devices from Percuvision, LLC

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Properties

Serial number

Other properties (14, all answered No)