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510(k) K133857

BRELLA-SPEC(TM) VAGINAL SPECULUM by Proa Medical, Inc. — Product Code HIB

K133857 is an FDA 510(k) premarket notification submitted by Proa Medical, Inc. for the device "BRELLA-SPEC(TM) VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on April 28, 2014. 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
April 28, 2014
Date Received
December 19, 2013
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

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  • 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)
  • K070964 — KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTE (May 18, 2007)

FDA data resources