Cleared Traditional

K113080 - TUBALGATOR

K113080 is the FDA 510(k) clearance for TUBALGATOR by Mectra Labs, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIN) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K113080 · Mectra Labs, Inc. · Obstetrics & Gynecology device
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Jun 2012
Decision
255d
Days
Class 2
Risk

K113080 is an FDA 510(k) clearance for the TUBALGATOR. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Mectra Labs, Inc. (Bloomfield, US). The FDA issued a Cleared decision on June 29, 2012 after a review of 255 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4150 - 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 Mectra Labs, Inc. devices

Submission Details

510(k) Number K113080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2011
Decision Date June 29, 2012
Days to Decision 255 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
95d slower than avg
Panel avg: 160d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4150
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 - HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

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