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510(k) K072762

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM by Depalt, Inc. — Product Code HIB

K072762 is an FDA 510(k) premarket notification submitted by Depalt, Inc. for the device "DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 22, 2008. 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
January 22, 2008
Date Received
September 28, 2007
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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  • K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (September 9, 2009)
  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
  • K070964 — KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTE (May 18, 2007)

FDA data resources