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510(k) K931215

HAND-TROL S by Aspen Labs — Product Code DWG

K931215 is an FDA 510(k) premarket notification submitted by Aspen Labs for the device "HAND-TROL S". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code DWG (Electrosurgical Device), a Class II device regulated under 21 CFR 878.4400. Aspen Labs has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
March 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical Device
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Aspen Labs

  • K970493 — HYFRECATOR 2000 (April 30, 1997)
  • K925333 — SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE (September 27, 1994)
  • K912046 — SINGLE USE LEE ELECTRODE (March 5, 1992)
  • K905654 — ELECTROSURGICAL UNIT WITH ACCESSORIES (March 18, 1991)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)

Other clearances for product code DWG

  • K942823 — MAHE INSTRUMENTS (December 5, 1994)
  • K932345 — TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE (April 12, 1994)
  • K925708 — DISPOSABLE ELECTROSURGERY BALL ELECTRODE (April 20, 1993)

FDA data resources