510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K022686Substantially Equivalent

Lap Surgical Systems Multiple Instrument Guide

Lap Surgical Systems, LLC, Roswell NM / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022686 is the FDA 510(k) clearance record for LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE, a class II device, cleared for Lap Surgical Systems, LLC on under FDA product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). FDA's definition for product code FED reads: "To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation". FDA records list one 510(k) clearance for Lap Surgical Systems, LLC. As of , FDA records show no recalls naming K022686.

Clearance record

Decision date
Received
(104 days to decision)
Product code
FED Endoscopic Access Overtube, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Lap Surgical Systems, LLC 100 N. Pennsylvania, Roswell NM
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FED

Trailing 12 months
5 clearances under product code FED in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20263
October 20260