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510(k) K020726

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE by Dukal Corp. — Product Code HIB

K020726 is an FDA 510(k) premarket notification submitted by Dukal Corp. for the device "DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Dukal Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
March 6, 2002
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 Dukal Corp.

  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K233262 — Dukal SMS Sterilization Wrap (March 22, 2024)
  • K083320 — DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE (March 6, 2009)
  • K070407 — DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE (March 26, 2007)
  • K061864 — DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, (September 15, 2006)
  • K984564 — ETHYL CHLORIDE DISPENSER (December 2, 1999)
  • K970457 — DUKAL ABD COMBINE PAD (May 8, 1997)
  • K970455 — DUKAL NON ADHERENT DRESSING (May 8, 1997)
  • K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)
  • K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)

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)

FDA data resources