510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971621Substantially Equivalent

Resistick Solid Laparoscopic Electrodes

Apyx Medical Corporation, St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971621 is the FDA 510(k) clearance record for RESISTICK SOLID LAPAROSCOPIC ELECTRODES, a class II device, cleared for Aaron Medical Industries on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 75 510(k) clearances for Apyx Medical Corporation, from to . As of , FDA records show no recalls naming K971621.

Clearance record

Decision date
Received
(50 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
Aaron Medical Industries 7100 30th Ave. N, St. Petersburg FL
510(k) summary
Statement
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