Cleared Special

Synvitro Hyadase (K200680) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200680 · Origio A/S, A Coopersurgical Company · Obstetrics & Gynecology device
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Jul 2020
Decision
123d
Days
Class 2
Risk

K200680 is an FDA 510(k) clearance for the Synvitro Hyadase. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Origio A/S, A Coopersurgical Company (Måløv, DK). The FDA issued a Cleared decision on July 17, 2020 after a review of 123 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Origio A/S, A Coopersurgical Company devices

Submission Details

510(k) Number K200680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2020
Decision Date July 17, 2020
Days to Decision 123 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
37d faster than avg
Panel avg: 160d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

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.

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