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Digital Video Processor SYS-5100

by Hunan Vathin Medical Instrument Co., Ltd

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) K202346

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06972197483994 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202346 Date19 Feb 2021DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Digital Video Processor
Generic name
Endoscopic video image processing unit
Model / reference
SYS-5100
Primary DI / UDI-DI
06972197483994
510(k) Number
FDA product code
EOQ
GMDN term
Endoscopic video image processing unit
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Other devices from Hunan Vathin Medical Instrument Co., Ltd

See all devices from Hunan Vathin Medical Instrument Co., Ltd →

Properties

  • Serial number
  • Manufacturing date

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No