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Stripper MXL3-Ind-275

by Origio Inc.

Stripper MXL3-Ind-275 is a Class II device made by Origio Inc., cleared under FDA 510(k) K993699 on 16 May 2000 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 20888937906381), 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) K993699

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 Number20888937906381 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK993699 Date16 May 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K993699 decided 16 May 2000 Active
  • FDA GUDID UDI-DI 20888937906381 listed 22 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K993699
  2. Listed FDA GUDID 20888937906381

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stripper
Generic name
Assisted reproduction microtool
Model / reference
MXL3-IND-275
Primary DI / UDI-DI
20888937906381
510(k) Number
FDA product code
MQH
GMDN term
Assisted reproduction microtool
Device class
Class II
Regulation number
884.6130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assisted reproduction microtool

Cleared under the same submission (K993699)

and 8 more cleared under K993699

Similar devices

Other devices filed under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)).

Other devices from Origio Inc.

See all devices from Origio Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)