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Silicone mat DJ-4928

by Efer Endoscopy

Silicone mat DJ-4928 is a Class II device made by Efer Endoscopy, cleared under FDA 510(k) K854414 on 12 Mar 1986 and listed in FDA GUDID since 14 Nov 2023 (UDI-DI G006DJ4928195), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K854414

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG006DJ4928195 UDI-DI Date14 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK854414 Date12 Mar 1986DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K854414 decided 12 Mar 1986 Active
  • FDA GUDID UDI-DI G006DJ4928195 listed 14 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K854414
  2. Listed FDA GUDID G006DJ4928195

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Silicone mat
Generic name
Rigid optical bronchoscope
Model / reference
DJ-4928
Primary DI / UDI-DI
G006DJ4928195
510(k) Number
FDA product code
EOQ
GMDN term
Rigid optical bronchoscope
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical bronchoscope

Cleared under the same submission (K854414)

and 8 more cleared under K854414

Similar devices

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

Other devices from Efer Endoscopy

See all devices from Efer Endoscopy →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)