Cleared Traditional

K140213 - DISPOSABLE ENDOSCOPIC CANNULA (FDA 510(k) Clearance)

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

K140213 · Dongguan Microview Medical Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
421d
Days
Class 2
Risk

K140213 is an FDA 510(k) clearance for the DISPOSABLE ENDOSCOPIC CANNULA. Classified as Cannula, Suction, Uterine (product code HGH), Class II - Special Controls.

Submitted by Dongguan Microview Medical Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on March 25, 2015 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Dongguan Microview Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K140213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2014
Decision Date March 25, 2015
Days to Decision 421 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 160d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGH Cannula, Suction, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
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.