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ICSI Pipette 15648

by Vitrolife AB

ICSI Pipette 15648 is a Class II device made by Vitrolife AB, cleared under FDA 510(k) K991104 on 19 Jul 1999 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 10805360018521), 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) K991104

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 Number10805360018521 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK991104 Date19 Jul 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991104 decided 19 Jul 1999 Active
  • FDA GUDID UDI-DI 10805360018521 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K991104
  2. Listed FDA GUDID 10805360018521

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ICSI Pipette
Generic name
User-induced micropipette
Model / reference
15648
Primary DI / UDI-DI
10805360018521
510(k) Number
FDA product code
MQH
GMDN term
User-induced micropipette
Device class
Class II
Regulation number
884.6130
GUDID distribution status
In Commercial Distribution

Related devices

Category: User-induced micropipette

Cleared under the same submission (K991104)

and 8 more cleared under K991104

Similar devices

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

Other devices from Vitrolife AB

See all devices from Vitrolife AB →

Properties

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