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510(k) K024302

PRECISION CAPILLARIES FOR MICROMANIPULATION by Brinkmann Instruments, Inc. — Product Code MQH

K024302 is an FDA 510(k) premarket notification submitted by Brinkmann Instruments, Inc. for the device "PRECISION CAPILLARIES FOR MICROMANIPULATION". The FDA issued a decision of Substantially Equivalent on February 19, 2003. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2003
Date Received
December 24, 2002
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

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  • 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)

FDA data resources