Cleared Traditional

LevaLap Laparoscopic Access Device (K212786) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212786 · Core Access Surgical Technologies, Inc. · Obstetrics & Gynecology device
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Feb 2022
Decision
175d
Days
Class 2
Risk

K212786 is an FDA 510(k) clearance for the LevaLap Laparoscopic Access Device. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Core Access Surgical Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 23, 2022 after a review of 175 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 Core Access Surgical Technologies, Inc. devices

Submission Details

510(k) Number K212786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2021
Decision Date February 23, 2022
Days to Decision 175 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
15d slower than avg
Panel avg: 160d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 47
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K212786.
Insufflator
K222812 · Scivita Medical Technology Co., Ltd. · May 2023
Gas Insufflator
K221995 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Mar 2023
EVA15 insufflator
K222901 · Palliare , Ltd. · Jan 2023
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K211104 · Conmed Corporation · Aug 2021
EVA15
K202799 · Palliare , Ltd. · Oct 2020
PNEUMOCLEAR
K201361 · W.O.M. World of Medicine GmbH · Jul 2020