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510(k) K922154

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION by Olsen Electrosurgical, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1994
Date Received
May 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Olsen Electrosurgical, Inc.

  • K912611 — OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE (April 15, 1992)
  • K913108 — TEFLON COATED ELECTRODES/ELECTRODES HANDLES (December 23, 1991)
  • K912612 — SMOKE/ODOR EVACUATOR #757 (November 1, 1991)
  • K885200 — 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE (January 13, 1989)
  • K885199 — #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES (January 13, 1989)
  • K884172 — MODIFIED OLSEN #770 DISPOSABLE HOLSTER (October 24, 1988)
  • K884171 — #875 DISPOSABLE BIOPOLAR CABLE (October 24, 1988)
  • K884175 — #820/821 BIPOLAR FORCEPS (October 24, 1988)
  • K884174 — MODIFIED OLSEN 755/756 SWITCHPENS (October 24, 1988)
  • K884173 — #920 DISPOSABLE TUR CABLE (October 24, 1988)

Other clearances for product code HIB

  • K252208 — JFord Speculum Sleeve™ (March 6, 2026)
  • K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM (April 28, 2014)
  • K132668 — IOB DISPOSABLE SPECULUM (January 17, 2014)
  • K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM (August 6, 2013)
  • K120743 — SPECULUM, VAGINAL, NONMETAL (March 23, 2012)
  • K110766 — KOLPLUX SYSTEM (September 15, 2011)
  • K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUM (February 16, 2010)
  • K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (September 9, 2009)
  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
  • K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (January 22, 2008)