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Sil-Select Plus Lower Layer SIP100LO

by Fertipro NV

Sil-Select Plus Lower Layer SIP100LO, an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Fertipro NV, was cleared under FDA 510(k) K053494 on 23 Mar 2006 and listed in FDA GUDID on 19 Sep 2016 (UDI-DI 54119670011566); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K053494

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 Number54119670011566 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053494 Date23 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053494 decided 23 Mar 2006 Active
  • FDA GUDID UDI-DI 54119670011566 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K053494
  2. Listed FDA GUDID 54119670011566

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sil-Select Plus Lower Layer
Generic name
IVF medium
Model / reference
SIP100LO
Primary DI / UDI-DI
54119670011566
510(k) Number
FDA product code
MQL
GMDN term
IVF medium
Device class
Class II
Regulation number
884.6180
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K053494)

and 8 more cleared under K053494

Similar devices

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

Other devices from Fertipro NV

  • VitriFreeze VF1001

    Class II

  • VitriFreeze VPI005

    Class II

  • VitriThaw VT3001

    Class II

  • VitriFreeze VF2001

    Class II

See all devices from Fertipro NV →

Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)