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510(k) K133257

BIOPSY PIPETTES by Research Instruments , Ltd. — Product Code MQH

K133257 is an FDA 510(k) premarket notification submitted by Research Instruments , Ltd. for the device "BIOPSY PIPETTES". The FDA issued a decision of Substantially Equivalent on May 16, 2014. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Research Instruments , Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2014
Date Received
October 23, 2013
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 Research Instruments , Ltd.

  • K141434 — SATURN 5 LASER (February 18, 2015)
  • K112413 — RI MSC (MIGRATION SEDIMENTATION CHAMBER) (July 13, 2012)
  • K083208 — SATURN ACTIVE LASER SYSTEM (August 25, 2009)
  • K060764 — SATURN 3 LASER SYSTEM (March 12, 2007)
  • K003142 — MICROMANIPULATOR (November 22, 2000)
  • K991261 — ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, AS (August 5, 1999)

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)
  • 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)
  • 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