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510(k) K061339

HIERSPEC SPECULUM by Medical Products Div. — Product Code HIB

K061339 is an FDA 510(k) premarket notification submitted by Medical Products Div. for the device "HIERSPEC SPECULUM". The FDA issued a decision of Substantially Equivalent on September 19, 2006. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2006
Date Received
May 15, 2006
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 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