Cleared Traditional

K150068 - Unimicro Veress Needle

K150068 is an FDA 510(k) clearance for Unimicro Veress Needle, manufactured by Unimicro Medical Systems (Shenzhen) Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K150068 · Unimicro Medical Systems (Shenzhen) Co., Ltd. · Obstetrics & Gynecology device
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Jul 2015
Decision
199d
Days
Class 2
Risk

K150068 is an FDA 510(k) clearance for the Unimicro Veress Needle. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Unimicro Medical Systems (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 31, 2015 after a review of 199 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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 Unimicro Medical Systems (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K150068

510(k) Number K150068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2015
Decision Date July 31, 2015
Days to Decision 199 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
39d slower than avg
Panel avg: 160d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 83
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K150068.
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K122180 · Olympus Medical Systems Corporation · Nov 2012
NEBULAE I
K120151 · Northgate Technologies, Inc. · Aug 2012
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation · Nov 2011