510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961695Substantially Equivalent

Endo-Tech Ltd., Tips

Ratio Design Lab, Alpheretta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961695 is the FDA 510(k) clearance record for ENDO-TECH LTD., TIPS, a class II device, cleared for Ratio Design Lab on under FDA product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)). FDA records list one 510(k) clearance for Ratio Design Lab. As of , FDA records show no recalls naming K961695.

Clearance record

Decision date
Received
(61 days to decision)
Product code
HFG Coagulator, Laparoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ratio Design Lab 4040 Nine Mcfarland, Suite 800, Alpheretta GA
510(k) summary
Summary
Third party review
No

Clearances, product code HFG

Trailing 12 months

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

FDA records show no clearances under product code HFG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFG, 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