510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912789Substantially Equivalent

Lm-100/200Low Flow Insufflator

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

K912789 is the FDA 510(k) clearance record for LM-100/200LOW FLOW INSUFFLATOR, a class II device, cleared for Leisegang Medical, Inc. on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list 10 510(k) clearances for Leisegang Medical, Inc., from to . As of , FDA records show no recalls naming K912789.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Leisegang Medical, Inc. 6401 Congress Ave., Boca Raton FL
510(k) summary
Statement
Third party review
No

Clearances, product code HIG

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