Cleared Traditional

K170799 - AP 50/30 Insufflator with Insuflow Port

K170799 is an FDA 510(k) clearance for AP 50/30 Insufflator with Insuflow Port, manufactured by Lexion Medical, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K170799 · Lexion Medical, LLC · Obstetrics & Gynecology device
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Nov 2017
Decision
242d
Days
Class 2
Risk

K170799 is an FDA 510(k) clearance for the AP 50/30 Insufflator with Insuflow Port. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on November 14, 2017 after a review of 242 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 Lexion Medical, LLC devices

FDA 510(k) Submission Details - K170799

510(k) Number K170799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date November 14, 2017
Days to Decision 242 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
82d slower than avg
Panel avg: 160d · This submission: 242d
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

Hrg
Bernard Horwath

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 124
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