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Touch Surgery MDS30028

by Covidien LP

Touch Surgery MDS30028 is a Class II device made by Covidien LP, cleared under FDA 510(k) K253984 on 4 Jun 2026 and listed in FDA GUDID since 23 Oct 2026 (UDI-DI 10884521856547), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K253984

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521856547 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253984 Date4 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253984 decided 4 Jun 2026 Active
  • FDA GUDID UDI-DI 10884521856547 listed 23 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253984
  2. Listed FDA GUDID 10884521856547

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Touch Surgery
Generic name
Medical image management system
Model / reference
MDS30028
Primary DI / UDI-DI
10884521856547
510(k) Number
FDA product code
SFE
GMDN term
Medical image management system
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

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See all devices from Covidien LP →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)