Biopsy Pipettes

510(k) Number

K133257 ↗

FDA product code

MQH

FDA applicant

Research Instruments , Ltd.

Device class

Class II

Regulation

21 CFR Part 884.6130

Advisory committee

Obstetrics/Gynecology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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

• Cook Flexipet G26713 K-FPIP-1170-10BS-5 by Cook Vandergrift Inc
• Cook Flexipet G46017 K-FPIP-1300-10 by Cook Vandergrift Inc
• STRIPPER MXL3-STR-CC by ORIGIO INC.
• MICROTOOLS by Conception Technology, Inc.
• LifeGlobal Micro Tips by LifeGlobal Group, LLC
• MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, by Cook Urological, Inc.
• STRIPPER MXL3-STR-PGD-CG by ORIGIO INC.
• BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB, 10-MBB-B, 10-MPB, 10-MPB-B by Humagen Fertility Diagnostics, Inc.
• CRYOTIP by Irvine Scientific Sales Co., Inc.
• INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING by Cook Ob/Gyn

• Integra 3

  Class II

  FDA 510(k) K003142 Active Cleared 22 Nov 2000 GUDID on market

• Fortuna 900E Ivf 240V Serial Number

  Class II

  GUDID on market

• EZ-Tip 125 micron tip id

  Class II

  FDA 510(k) K161275 Active Cleared 23 Jan 2017 GUDID on market

• CODA K59549 Coda Inline Filter for G185 US

  Class II

  GUDID on market

See all devices from Research Instruments, Ltd. →