510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101606Substantially Equivalent

Micromed Pd-8K Insulation Defect Detector

Mcgan Technology, LLC, Middletown CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101606 is the FDA 510(k) clearance record for MICROMED PD-8K INSULATION DEFECT DETECTOR, a class II device, cleared for Mcgan Technology, LLC on under FDA product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)). FDA records list one 510(k) clearance for Mcgan Technology, LLC. As of , FDA records show no recalls naming K101606.

Clearance record

Decision date
Received
(115 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
Mcgan Technology, LLC 410 Ridge Rd., Middletown CT
510(k) summary
Summary PDF
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