Cleared Traditional

K162648 - U-Blade Veress Needle

K162648 is an FDA 510(k) clearance for U-Blade Veress Needle, manufactured by Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K162648 · Tianjin Uwell Medical Device Manufacturing Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2016
Decision
81d
Days
Class 2
Risk

K162648 is an FDA 510(k) clearance for the U-Blade Veress Needle. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Tianjin Uwell Medical Device Manufacturing Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on December 12, 2016 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tianjin Uwell Medical Device Manufacturing Co., Ltd. devices

FDA 510(k) Submission Details - K162648

510(k) Number K162648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2016
Decision Date December 12, 2016
Days to Decision 81 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
79d faster than avg
Panel avg: 160d · This submission: 81d
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 93
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K162648.
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HIGH FLOW INSUFFLANTION UNIT
K122180 · Olympus Medical Systems Corporation · Nov 2012
NEBULAE I
K120151 · Northgate Technologies, Inc. · Aug 2012