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510(k) K904240

SINGLE USE LAPARSCOPIC ELECTRODE by Aspen Labs — Product Code HFG

K904240 is an FDA 510(k) premarket notification submitted by Aspen Labs for the device "SINGLE USE LAPARSCOPIC ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 19, 1991. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Aspen Labs has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
September 13, 1990
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 by Aspen Labs

  • K970493 — HYFRECATOR 2000 (April 30, 1997)
  • K925333 — SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE (September 27, 1994)
  • K931215 — HAND-TROL S (March 28, 1994)
  • K912046 — SINGLE USE LEE ELECTRODE (March 5, 1992)
  • K905654 — ELECTROSURGICAL UNIT WITH ACCESSORIES (March 18, 1991)

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)
  • K101606 — MICROMED PD-8K INSULATION DEFECT DETECTOR (October 1, 2010)
  • 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)
  • K902555 — AMCATH COAGULATION PROBE (June 20, 1990)

FDA data resources