Cleared Special

K033903 - MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,

K033903 is an FDA 510(k) clearance for MODIFICATION TO INTRACYTOPLASMIC SPERM ..., manufactured by Cook Urological, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Special 510(k) pathway after a 30-day FDA review.

K033903 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
30d
Days
Class 2
Risk

K033903 is an FDA 510(k) clearance for the MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPE.... Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033903

510(k) Number K033903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2003
Decision Date January 16, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 161d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQH Microtools, Assisted Reproduction (pipettes)

All 25
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K033903.
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
K072600 · Sunlight Medical, Inc. · May 2008
THE STRIPPER PGD
K041435 · Mid-Atlantic Diagnostics, Inc. · Sep 2004
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc. · Aug 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · Cook Urological, Inc. · Jan 2004
PRECISION CAPILLARIES FOR MICROMANIPULATION
K024302 · Brinkmann Instruments, Inc. · Feb 2003
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
K022643 · Swemed Lab International AB · Nov 2002
K033903 · MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
Download PDF FDA Summary Cook Urological, Inc.