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Seal Ring Maj-1963

by Olympus Medical Systems Corporation

Seal Ring Maj-1963, a surgical instrument seal/seal maintenance set (FDA Class II; FDA product code FDF, Colonoscope and accessories, flexible/rigid) made by Olympus Medical Systems Corporation, was cleared under FDA 510(k) K103312 on 12 May 2011 and listed in FDA GUDID on 21 Sep 2016 (UDI-DI 04953170305863); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K103312

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170305863 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103312 Date12 May 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103312 decided 12 May 2011 Active
  • FDA GUDID UDI-DI 04953170305863 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103312
  2. Listed FDA GUDID 04953170305863

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Seal Ring
Generic name
Surgical instrument seal/seal maintenance set
Model / reference
MAJ-1963
Primary DI / UDI-DI
04953170305863
FDA product code
FDF
GMDN term
Surgical instrument seal/seal maintenance set
Device class
Class II
Regulation number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K103312)

and 4 more cleared under K103312

Similar devices

Other devices filed under FDA product code FDF (Colonoscope and accessories, flexible/rigid).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)