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510(k) K944450

SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE by Unimed Surgical Products, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
September 12, 1994
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 Unimed Surgical Products, Inc.

  • K132224 — UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES (October 8, 2013)
  • K993647 — UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TI (November 16, 1999)
  • K970066 — UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE (February 18, 1997)
  • K963338 — UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH (October 21, 1996)
  • K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE (September 3, 1996)
  • K944265 — NEEDLE ELCTRODE (May 5, 1995)
  • K946246 — SURGI-LINK BIPOLAR MICRO FORCEPS (March 7, 1995)
  • K945030 — SURGI-LINK LAPAROSCOPIC ELECTRODES (November 3, 1994)
  • K944898 — SURGI-LINK BIPOLAR ELECTRODES (November 1, 1994)
  • K944617 — SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL (September 29, 1994)

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)