Cleared Traditional

K983596 - INTRACYTOPLASMIC SPERM INJECTION (ICSI)...

K983596 is the FDA 510(k) clearance for INTRACYTOPLASMIC SPERM INJECTION (ICSI)... by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code MQH) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K983596 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
115d
Days
Class 2
Risk

K983596 is an FDA 510(k) clearance for the INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIP.... Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 5, 1999 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Ob/Gyn devices

Submission Details

510(k) Number K983596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date February 05, 1999
Days to Decision 115 days
Submission Type Traditional
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
45d faster than avg
Panel avg: 160d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K983596.
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc. · Aug 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903 · Cook Urological, Inc. · Jan 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · Cook Urological, Inc. · Jan 2004