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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 161d · 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 142
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K150068.
U-Blade Veress Needle
K162648 · Tianjin Uwell Medical Device Manufacturing Co., Ltd. · Dec 2016
S698 Symbioz flow
K153367 · Sopro - Acteon Group · Jun 2016
Insufflator 50L FM134
K153513 · W.O.M. World of Medicine GmbH · Mar 2016
SurgiQuest AirSeal iFS System
K143404 · Surgiquest, Inc. · Mar 2015
InsufflatOR Needle
K142700 · Gynetech Pty. , Ltd. · Dec 2014
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
K140263 · Lexion Medical, LLC · Mar 2014