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510(k) K030693

KENTEX DISPOSABLE VAGINAL SPECULUM by Kentron Health Care, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2003
Date Received
March 5, 2003
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 Kentron Health Care, Inc.

  • K971917 — KENTRON'S ISOLATION GOWN (September 19, 1997)
  • K972410 — IMPERVIOUS ISOLATION GOWN (September 19, 1997)
  • K953465 — KENTEMP (December 15, 1995)
  • K953914 — KENTEX (November 6, 1995)
  • K953830 — KENSORB (October 3, 1995)

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)