Skip to content

Midas Rex PA305

by Medtronic Powered Surgical Solutions

Midas Rex PA305 is a Class I device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K183515 on 12 May 2019 and listed in FDA GUDID since 8 Jun 2019 (UDI-DI 20763000241951), 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) K183515

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 Number20763000241951 UDI-DI Date8 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183515 Date12 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183515 decided 12 May 2019 Active
  • FDA GUDID UDI-DI 20763000241951 listed 8 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K183515
  2. Listed FDA GUDID 20763000241951

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Midas Rex
Generic name
Surgical instrument/endoscope cleaning utensil, reusable
Model / reference
PA305
Primary DI / UDI-DI
20763000241951
510(k) Number
FDA product code
GEE
GMDN term
Surgical instrument/endoscope cleaning utensil, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Surgical instrument/endoscope cleaning utensil, reusable.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)