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Medichoice ES27520

by Owens & Minor Distribution, Inc.

Medichoice ES27520 is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K081647 on 12 Aug 2008 and listed in FDA GUDID since 20 Aug 2016 (UDI-DI 10885632110016), 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) K081647

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 Number10885632110016 UDI-DI Date20 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081647 Date12 Aug 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081647 decided 12 Aug 2008 Active
  • FDA GUDID UDI-DI 10885632110016 listed 20 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081647
  2. Listed FDA GUDID 10885632110016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medichoice
Generic name
Soft-tissue ultrasonic surgical system
Model / reference
ES27520
Primary DI / UDI-DI
10885632110016
510(k) Number
FDA product code
GEI
GMDN term
Soft-tissue ultrasonic surgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Soft-tissue ultrasonic surgical system

Cleared under the same submission (K081647)

and 8 more cleared under K081647

Similar devices in this category

Other devices filed under Soft-tissue ultrasonic surgical system.

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)