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MENTOR Tissue Expander 350-4309MD

by Mentor Texas LP

MENTOR Tissue Expander 350-4309MD is a device classified as Unclassified made by Mentor Texas LP, cleared under FDA 510(k) K842883 on 17 Aug 1984 and listed in FDA GUDID since 15 Jun 2026 (UDI-DI 10081317028878), active as of 23 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 23 Oct 2026

Documents

510(k) K842883

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10081317028878 UDI-DI Date15 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK842883 Date17 Aug 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K842883 decided 17 Aug 1984 Active
  • FDA GUDID UDI-DI 10081317028878 listed 15 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K842883
  2. Listed FDA GUDID 10081317028878

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MENTOR Tissue Expander
Generic name
Skin-port tissue expander
Model / Ref / Catalog
350-4309MD
Primary DI / UDI-DI
10081317028878
510(k) Number
FDA product code
LCJ
GMDN term
Skin-port tissue expander
Device class
U
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K842883)

and 8 more cleared under K842883

Other devices from Mentor Texas LP

See all devices from Mentor Texas LP →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)