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SlimLine REXMRO-715A

by Gyrus Acmi, Inc.

SlimLine REXMRO-715A is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K012758 on 9 Apr 2002 and listed in FDA GUDID since 24 Jul 2024 (UDI-DI 00821925010987), 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) K012758

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 Number00821925010987 UDI-DI Date24 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012758 Date9 Apr 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012758 decided 9 Apr 2002 Active
  • FDA GUDID UDI-DI 00821925010987 listed 24 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012758
  2. Listed FDA GUDID 00821925010987

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SlimLine
Generic name
Rigid optical ureteroscope
Model / reference
REXMRO-715A
Primary DI / UDI-DI
00821925010987
510(k) Number
FDA product code
FGB
GMDN term
Rigid optical ureteroscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical ureteroscope

Cleared under the same submission (K012758)

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)