Cleared Traditional

NUNC IVF MULTIDISH 4 WELLS NUNCLON (K040717) - FDA 510(k) Clearance

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

K040717 · Nunc A/S · Obstetrics & Gynecology device
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Aug 2004
Decision
146d
Days
Class 2
Risk

K040717 is an FDA 510(k) clearance for the NUNC IVF MULTIDISH 4 WELLS NUNCLON. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Nunc A/S (Roskilde, DK). The FDA issued a Cleared decision on August 12, 2004 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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 Nunc A/S devices

Submission Details

510(k) Number K040717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2004
Decision Date August 12, 2004
Days to Decision 146 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 160d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 - MQK Labware, Assisted Reproduction

All 49
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