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TAS Medical, Inc. Tissue Approximation System T-4000

by TAS Medical, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197644217267 UDI-DI Date6 Nov 2023ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1294-2025 FDA Class II initiated 27 Jan 2025

    Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TAS Medical, Inc. Tissue Approximation System
Generic Name
Nylon suture, non-bioabsorbable, monofilament
Model / Ref / Catalog
T-4000
Primary DI / UDI-DI
00197644217267
510(k) Number
FDA Product Code
GAR
GMDN Term
Nylon suture, non-bioabsorbable, monofilament
Device Class
Class II
Regulation Number
878.5020
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe
Size
Length — 37 Centimeter
Width — 2.7 Millimeter
Height — 1.4 Micrometer

Related devices

Cleared under the same submission (K220980)

Other devices from TAS Medical, Inc.

See all devices from TAS Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No