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Elmed ST52732404E

by Elmed Incorporated

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) K181173

FDA submission, from GUDID

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 Number00198506044366 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181173 Date22 Mar 2019DecidedStatusActive

Official records

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Elmed
Generic name
Laparoscopic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
ST52732404E
Primary DI / UDI-DI
00198506044366
510(k) Number
FDA product code
GCJ
GMDN term
Laparoscopic surgical procedure kit, non-medicated, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K181173)

Show all (12)

Other devices from Elmed Incorporated

See all devices from Elmed Incorporated →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (11)

  • Supplied 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