Elmed 5-0524-19A

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

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00842180140073 UDI-DI	Date27 Sep 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK181173	Date22 Mar 2019Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Elmed
Generic name: Rigid endoscopic tissue manipulation forceps, reusable
Model / Ref / Catalog: 5-0524-19A

Primary DI / UDI-DI: 00842180140073
510(k) Number: K181173
FDA product code: GEI
GMDN term: Rigid endoscopic tissue manipulation forceps, reusable

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Elmed Incorporated

Elmed Incorporated ST129100

Class I
Elmed Incorporated 12-9100

Class I
Elmed Incorporated STT9920FSAN

Class I
Elmed Incorporated STT9931FSANT

Class I
Elmed Incorporated STT9924FSAN

Class I
Elmed Incorporated ST9932FSANT

Class I

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