Cleared Traditional

K232401 - Disposable Veress Needles

K232401 is an FDA 510(k) clearance for Disposable Veress Needles, manufactured by Hangzhou Kangji Medical Instrument Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K232401 · Hangzhou Kangji Medical Instrument Co., Ltd. · Obstetrics & Gynecology device
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Dec 2023
Decision
126d
Days
Class 2
Risk

K232401 is an FDA 510(k) clearance for the Disposable Veress Needles. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Hangzhou Kangji Medical Instrument Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 14, 2023 after a review of 126 days - within the typical 510(k) review window.

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 Hangzhou Kangji Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K232401

510(k) Number K232401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2023
Decision Date December 14, 2023
Days to Decision 126 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
34d faster than avg
Panel avg: 160d · This submission: 126d
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 Consultant

Shanghai Lingfu Technology Co., Ltd.
Esther Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 91
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K232401.
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