510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212786Substantially Equivalent

LevaLap Laparoscopic Access Device

Core Access Surgical Technologies, Inc., Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212786 is the FDA 510(k) clearance record for LevaLap Laparoscopic Access Device, a class II device, cleared for Core Access Surgical Technologies, Inc. on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list one 510(k) clearance for Core Access Surgical Technologies, Inc. As of , FDA records show no recalls naming K212786.

Clearance record

Decision date
Received
(175 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Core Access Surgical Technologies, Inc. 3495 Piedmont Rd., NE Bldg. 11, Suite 905, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260