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510(k) K951528

AMSINO DISPOSABLE VIGINAL SPECULUM by Amsino Intl., Inc. — Product Code HIB

K951528 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSINO DISPOSABLE VIGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
April 3, 1995
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 Amsino Intl., Inc.

  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (January 12, 2000)
  • K974042 — AMSURE CLEANSING ENEMA SET (December 19, 1997)
  • K973107 — AMSINO I.V. ADMINISTRATION SET (October 2, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K950780 — AMSINO CERVICAL SCRAPER (July 25, 1995)

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