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CORE-Trocar IC-TC12

by Incore Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08800035701505 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CORE-Trocar
Generic Name
Laparoscopic access cannula, single-use
Model / Reference
IC-TC12
Primary DI / UDI-DI
08800035701505
510(k) Number
FDA Product Code
GCJ
GMDN Term
Laparoscopic access cannula, single-use
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K211148)

Other devices from Incore Co., Ltd.

See all devices from Incore Co., Ltd. →

Properties

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

Other properties (9)

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