510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924134Substantially Equivalent

Leisegang Laparoscopic Irrigation System/access

Leisegang Medical, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924134 is the FDA 510(k) clearance record for LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS, a class II device, cleared for Leisegang Medical, Inc. on under FDA product code GCS (Endoscope, Battery-Powered And Accessories). FDA records list 10 510(k) clearances for Leisegang Medical, Inc., from to . As of , FDA records show no recalls naming K924134.

Clearance record

Decision date
Received
(318 days to decision)
Product code
GCS Endoscope, Battery-Powered And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Leisegang Medical, Inc. 6401 Congress Ave., Boca Raton FL
510(k) summary
Statement
Third party review
No

Clearances, product code GCS

Trailing 12 months

FDA records hold no clearances under product code GCS in the trailing twelve months.

FDA records show no clearances under product code GCS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260