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DirectVision MA100282

by Percuvision, LLC

DirectVision MA100282 is an indwelling urethral drainage balloon catheter (FDA Class II; FDA product code EZL, Catheter, Retention Type, Balloon) made by Percuvision, LLC, cleared under FDA 510(k) K110214 on 27 May 2011 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00855308006007), 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

510(k) K110214

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855308006007 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110214 Date27 May 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110214 decided 27 May 2011 Active
  • FDA GUDID UDI-DI 00855308006007 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110214
  2. Listed FDA GUDID 00855308006007

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DirectVision
Generic name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / reference
MA100282
Primary DI / UDI-DI
00855308006007
510(k) Number
FDA product code
EZL
GMDN term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device class
Class II
Regulation number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 14 French

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K110214)

Similar devices in this category

Other devices filed under Indwelling urethral drainage balloon catheter, non-antimicrobial.

Other devices from Percuvision, LLC

See all devices from Percuvision, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)