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510(k) K192146

V-DENUPET by Vitromed GmbH — Product Code MQH

K192146 is an FDA 510(k) premarket notification submitted by Vitromed GmbH for the device "V-DENUPET". The FDA issued a decision of Substantially Equivalent on January 28, 2020. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Vitromed GmbH has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2020
Date Received
August 8, 2019
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 Vitromed GmbH

  • K241833 — V-GRAD (March 21, 2025)
  • K240176 — V-VITFREEZE and V-VITWARM (September 13, 2024)
  • K232125 — V-PVP (March 20, 2024)
  • K222606 — V-HYADASE (May 26, 2023)
  • K223117 — V-SPERM WASH (January 31, 2023)
  • K193285 — V-ONESTEP (November 20, 2020)

Other clearances for product code MQH

  • K250838 — Denudation Pipettes (July 3, 2025)
  • K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (January 23, 2017)
  • K152581 — LifeGlobal Micro Tips (April 11, 2016)
  • 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