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Single Use Guide Sheath Kit K-201

by Olympus Medical Systems Corporation GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170245466 UDI-DIDate21 Sep 2018ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Single Use Guide Sheath Kit
Generic Name
Flexible endoscopic biopsy forceps, single-use
Model / Reference
K-201
Primary DI / UDI-DI
04953170245466
FDA Product Code
EOQ
GMDN Term
Flexible endoscopic biopsy forceps, single-use
Device Class
Class II
Regulation Number
874.4680
GUDID distribution status
Not in Commercial Distribution

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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

Other properties (8)

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