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510(k) K041757

FEMSPEC DISPOSABLE VAGINAL SPECULUM by Femspec LLC — Product Code HIB

K041757 is an FDA 510(k) premarket notification submitted by Femspec LLC for the device "FEMSPEC DISPOSABLE VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on December 23, 2004. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Femspec LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2004
Date Received
June 29, 2004
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 Femspec LLC

  • K060320 — FEMECC ENDOCERVICAL CURETTE (July 28, 2006)
  • K052192 — FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I (February 2, 2006)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)

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