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Elmed 52600-01

by Elmed Incorporated

Elmed 52600-01 is a Class II device made by Elmed Incorporated, cleared under FDA 510(k) K974382 on 21 Apr 1998 and listed in FDA GUDID since 8 Feb 2018 (UDI-DI 00842180110625), active as of 22 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 22 Oct 2026

Documents

510(k) K974382

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 Number00842180110625 UDI-DI Date8 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974382 Date21 Apr 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974382 decided 21 Apr 1998 Active
  • FDA GUDID UDI-DI 00842180110625 listed 8 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K974382
  2. Listed FDA GUDID 00842180110625

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Elmed
Generic name
Rigid endoscopic scissors, single-use
Model / Ref / Catalog
52600-01
Primary DI / UDI-DI
00842180110625
510(k) Number
FDA product code
GCJ
GMDN term
Rigid endoscopic scissors, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid endoscopic scissors, single-use

Cleared under the same submission (K974382)

and 8 more cleared under K974382

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from Elmed Incorporated

See all devices from Elmed Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)