Cleared Traditional

K212786 - LevaLap Laparoscopic Access Device

K212786 is an FDA 510(k) clearance for LevaLap Laparoscopic Access Device, manufactured by Core Access Surgical Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 175-day FDA review.

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

FDA 510(k) Submission Details - K212786

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.

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 92
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K212786.
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K201361 · W.O.M. World of Medicine GmbH · Jul 2020