Cleared Traditional

K041562 - CRYOTIP (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041562 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
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Aug 2004
Decision
60d
Days
Class 2
Risk

K041562 is an FDA 510(k) clearance for the CRYOTIP. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 9, 2004 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Irvine Scientific Sales Co., Inc. devices

Submission Details

510(k) Number K041562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2004
Decision Date August 09, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 160d · This submission: 60d
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.