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510(k) K022948

VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L by Medical Action Industries, Inc. — Product Code HIB

K022948 is an FDA 510(k) premarket notification submitted by Medical Action Industries, Inc. for the device "VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L". The FDA issued a decision of Substantially Equivalent on November 4, 2002. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Medical Action Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2002
Date Received
September 5, 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 Medical Action Industries, Inc.

  • K042526 — DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON S (April 25, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)
  • K946019 — SURGICLA INSTRUMENT KIT (March 20, 1995)
  • K923846 — BURN DRESSING (September 11, 1992)
  • K884826 — GAUZE SPONGE (December 22, 1988)
  • K810685 — SUTURE REMOVAL KIT (March 26, 1981)
  • K810184 — LAPAROTOMY SPONGE (February 4, 1981)

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