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510(k) K931437

MODEL 80-1983, ELECTROSURGICAL GENERATOR by Cameron-Miller, Inc. — Product Code HGI

K931437 is an FDA 510(k) premarket notification submitted by Cameron-Miller, Inc. for the device "MODEL 80-1983, ELECTROSURGICAL GENERATOR". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Cameron-Miller, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
March 22, 1993
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 Cameron-Miller, Inc.

  • K944775 — ELECTROSURGICAL UNIT MODEL 26-0335 (October 11, 1994)
  • K931541 — MODEL 26-0375, ELECTROSURGICAL GENERATOR (June 1, 1994)
  • K935490 — ELECTROSURGICAL DEVICE, MODEL 26-2500 (April 1, 1994)
  • K853972 — CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR (January 24, 1986)
  • K854109 — ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 (January 24, 1986)
  • K833449 — HAND CONTROLLED PENCIL OR SWITCH HAND (November 29, 1983)
  • K822092 — CAMERON-MILLER #40-1516 (September 21, 1982)
  • K812702 — TECHNICATOR (November 5, 1981)
  • K791415 — MODEL 80-1765 ELECTROSURGICAL UNIT (October 11, 1979)
  • K781353 — PAPILLOTOME CUTTING SNARE (October 10, 1978)

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