510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K933300Substantially Equivalent

Geister Surgical Int'l Monopolar Endoscopic Surg.inst.

Lyle Howard Corp., Lebanon NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933300 is the FDA 510(k) clearance record for GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST., a class II device, cleared for Lyle Howard Corp. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list one 510(k) clearance for Lyle Howard Corp. As of , FDA records show no recalls naming K933300.

Clearance record

Decision date
Received
(450 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lyle Howard Corp. Round Valley Plz., Lebanon NJ
510(k) summary
Summary
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, 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 20261
October 20260