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510(k) K152581

LifeGlobal Micro Tips by Life Global Group, LLC — Product Code MQH

K152581 is an FDA 510(k) premarket notification submitted by Life Global Group, LLC for the device "LifeGlobal Micro Tips". The FDA issued a decision of Substantially Equivalent on April 11, 2016. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Life Global Group, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2016
Date Received
September 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

Other clearances by Life Global Group, LLC

  • K142991 — LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, (February 17, 2015)
  • K143498 — LifeGlobal Global HP (January 20, 2015)

Other clearances for product code MQH

  • K250838 — Denudation Pipettes (July 3, 2025)
  • K192146 — V-DENUPET (January 28, 2020)
  • K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (January 23, 2017)
  • K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pi (January 8, 2016)
  • K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette (December 18, 2015)
  • K133257 — BIOPSY PIPETTES (May 16, 2014)
  • K102480 — INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZO (April 19, 2011)
  • K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (April 30, 2010)
  • K072600 — INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL (May 19, 2008)
  • K041435 — THE STRIPPER PGD (September 29, 2004)

FDA data resources