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510(k) K912046

SINGLE USE LEE ELECTRODE by Aspen Labs — Product Code HGI

K912046 is an FDA 510(k) premarket notification submitted by Aspen Labs for the device "SINGLE USE LEE ELECTRODE". The FDA issued a decision of Substantially Equivalent on March 5, 1992. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Aspen Labs has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1992
Date Received
May 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
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)
  • K905654 — ELECTROSURGICAL UNIT WITH ACCESSORIES (March 18, 1991)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM (January 3, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K022593 — THOMAS MEDICAL ELECTRODES (November 1, 2002)
  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)

FDA data resources