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EmbryoGen 12040003M

by CooperSurgical, Inc.

EmbryoGen 12040003M is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by CooperSurgical, Inc., cleared under FDA 510(k) K140317 on 16 Jun 2014 and listed in FDA GUDID since 4 Feb 2026 (UDI-DI 00888937029468), 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) K140317

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 Number00888937029468 UDI-DI Date4 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140317 Date16 Jun 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140317 decided 16 Jun 2014 Active
  • FDA GUDID UDI-DI 00888937029468 listed 4 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140317
  2. Listed FDA GUDID 00888937029468

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EmbryoGen
Generic name
IVF medium
Model / reference
12040003M
Primary DI / UDI-DI
00888937029468
510(k) Number
FDA product code
MQL
GMDN term
IVF medium
Device class
Class II
Regulation number
884.6180
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K140317)

Similar devices

Other devices filed under FDA product code MQL (Media, Reproductive).

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

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