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Single Use Aspiration Needle Na-U401SX-4025N

by Olympus Medical Systems Corporation 4 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number04953170402012 UDI-DI Date10 Feb 2020ListedStatusListed GUDID: not 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  • Withdrawn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
Single Use Aspiration Needle
Generic Name
Flexible endoscopic biopsy handpiece/needle
Model / Reference
NA-U401SX-4025N
Primary DI / UDI-DI
04953170402012
510(k) Number
FDA Product Code
KTI
GMDN Term
Flexible endoscopic biopsy handpiece/needle
Device Class
Class II
Regulation Number
874.4680
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K190239)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

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