Cleared Traditional

K060699 - SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)

K060699 is an FDA 510(k) clearance for SYNVITRO CUMULASE (HYALURONIDASE MEDIUM), manufactured by Medicult A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K060699 · Medicult A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
55d
Days
Class 2
Risk

K060699 is an FDA 510(k) clearance for the SYNVITRO CUMULASE (HYALURONIDASE MEDIUM). Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Medicult A/S (San Diego, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 55 days - a notably fast clearance cycle.

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: 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 Medicult A/S devices

FDA 510(k) Submission Details - K060699

510(k) Number K060699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2006
Decision Date May 10, 2006
Days to Decision 55 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
105d faster than avg
Panel avg: 160d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

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 Peers - MQL Media, Reproductive

All 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K060699.
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc. · Aug 2006
BIOPSY MEDIUM, MODEL REF 1062
K060983 · Medicult A/S · Jul 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
K053552 · Intl., Inc. · May 2006
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
K053551 · 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