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510(k) K844625

BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY by Bipore, Inc. — Product Code KOZ

K844625 is an FDA 510(k) premarket notification submitted by Bipore, Inc. for the device "BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY". The FDA issued a decision of Substantially Equivalent on January 16, 1985. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Bipore, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1985
Date Received
November 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Beads, Hydrophilic, For Wound Exudate Absorption
Device Class
Class I
Regulation Number
878.4018
Review Panel
SU
Submission Type

Other clearances by Bipore, Inc.

  • K073434 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (April 1, 2008)
  • K073318 — BIPORE BALLOON DILATION CATHETER (January 16, 2008)
  • K051513 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (December 7, 2005)
  • K041293 — BIOPORE BALLOON DILATION CATHETER (July 9, 2004)
  • K983650 — BIPORE BALLOON DILATATION CATHETER (February 17, 1999)
  • K973563 — BIPORE BALLOON DILATATION CATHETER (April 1, 1998)
  • K964814 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (May 7, 1997)
  • K961980 — BIPORE BALLOON DILATATION CATHETER (September 12, 1996)
  • K862015 — O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER (July 22, 1986)

Other clearances for product code KOZ

  • K905206 — INCARE PINSITE DRESSING (April 12, 1991)
  • K905688 — CUTINOVA HYDRO (April 1, 1991)
  • K905069 — IODOSORB GEL (January 31, 1991)
  • K904604 — REDI-RELEASE ABSORBENT DRESSING (January 7, 1991)
  • K903645 — DERMASORB WOUND CONTACT LAYER DRESSING (November 21, 1990)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K904412 — ALLEVYN DRESSING CLAIMS CHANGE (October 23, 1990)
  • K901876 — INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) (June 28, 1990)
  • K896176 — EXUSORB(TM) DRY/WET DRESSING (November 24, 1989)
  • K895354 — INTRASITE CAVITY WOUND DRESSING (November 7, 1989)

FDA data resources