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Selebrek PTCA Balloon Dilatation Catheter KCTO150030

by Kossel Medtech (Suzhou) 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 22 Oct 2026

Documents

None

No authorization documents

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 Number06971591769147 UDI-DI Date19 Apr 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Selebrek PTCA Balloon Dilatation Catheter
Generic Name
Endoscopic electrosurgical submucosal lift/resection set
Model / Reference
KCTO150030
Primary DI / UDI-DI
06971591769147
510(k) Number
FDA Product Code
LOX
GMDN Term
Endoscopic electrosurgical submucosal lift/resection set
Device Class
Class II
Regulation Number
870.5100
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K211349)

Other devices from Kossel Medtech (Suzhou) Co., Ltd.

See all devices from Kossel Medtech (Suzhou) 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