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PENTAX Medical OS-A83

by Pentax Medical Company 2 variants

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 Number04580826928987 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  • Withdrawn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
PENTAX Medical
Generic Name
Endoscopic device remote control
Model / Reference
OS-A83
Primary DI / UDI-DI
04580826928987
510(k) Number
FDA Product Code
PEA
GMDN Term
Endoscopic device remote control
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K150618)

Show all (9)

Other devices from Pentax Medical Company

See all devices from Pentax Medical Company →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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