Cleared Traditional

K053551 - MICROMANIPULATION MEDIA SYSTEM

K053551 is the FDA 510(k) clearance for MICROMANIPULATION MEDIA SYSTEM by Intl., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K053551 · Intl., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
140d
Days
Class 2
Risk

K053551 is an FDA 510(k) clearance for the MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Gilford, US). The FDA issued a Cleared decision on May 9, 2006 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Intl., Inc. devices

Submission Details

510(k) Number K053551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date May 09, 2006
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 160d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 Consultant

Intl., Inc.
MICHAEL D CECCHI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

All 141
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K053551.
LG SPERM FREEZING
K070689 · Intl., Inc. · Jul 2007
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc. · Aug 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
K053552 · Intl., Inc. · May 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168 · Irvine Scientific Sales Co., Inc. · Apr 2006
ICSI-100
K043116 · Vitrolife Sweden AB · Jan 2005
MEDIA CULTURE SYSTEM
K040530 · Intl., Inc. · Jun 2004