Cleared Traditional

K171139 - LaparoLight Veress Needle

K171139 is an FDA 510(k) clearance for LaparoLight Veress Needle, manufactured by Buffalo Filter, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K171139 · Buffalo Filter, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
30d
Days
Class 2
Risk

K171139 is an FDA 510(k) clearance for the LaparoLight Veress Needle. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Buffalo Filter, LLC (Lancaster, US). The FDA issued a Cleared decision on May 18, 2017 after a review of 30 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.

FDA 510(k) Submission Details - K171139

510(k) Number K171139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2017
Decision Date May 18, 2017
Days to Decision 30 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 161d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Mark Job

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 158
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K171139.
TEMED Gas Diffuser
K173545 · Temed · Feb 2018
AP 50/30 Insufflator with Insuflow Port
K170799 · Lexion Medical, LLC · Nov 2017
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
K162582 · Fisher & Paykel Healthcare · Jun 2017
PNEUMOCLEAR
K170784 · W.O.M. World of Medicine GmbH · May 2017
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
U-Blade Veress Needle
K162648 · Tianjin Uwell Medical Device Manufacturing Co., Ltd. · Dec 2016

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.