Home / 510(k) Clearances / K101606

510(k) K101606

MICROMED PD-8K INSULATION DEFECT DETECTOR by Mcgan Technology, LLC — Product Code HFG

K101606 is an FDA 510(k) premarket notification submitted by Mcgan Technology, LLC for the device "MICROMED PD-8K INSULATION DEFECT DETECTOR". The FDA issued a decision of Substantially Equivalent on October 1, 2010. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2010
Date Received
June 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances for product code HFG

  • K181124 — Acessa ProVu System (September 28, 2018)
  • K132744 — ACESSA GUIDANCE SYSTEM (May 27, 2014)
  • K132184 — ACESSA GUIDANCE HANDPIECE (April 28, 2014)
  • K121858 — THE ABLATION SYSTEM (November 5, 2012)
  • K991424 — INSULSCAN INSULATION TESTING SYSTEM (July 22, 1999)
  • K961695 — ENDO-TECH LTD., TIPS (July 1, 1996)
  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K915406 — DAVOL ELECTROSUGICAL PROBES (February 28, 1992)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)
  • K902555 — AMCATH COAGULATION PROBE (June 20, 1990)

FDA data resources