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510(k) K000227

UMBICUT by Pollak (Intl.), Ltd. — Product Code HFW

K000227 is an FDA 510(k) premarket notification submitted by Pollak (Intl.), Ltd. for the device "UMBICUT". The FDA issued a decision of Substantially Equivalent on April 27, 2000. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Pollak (Intl.), Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2000
Date Received
January 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Umbilical
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Pollak (Intl.), Ltd.

  • K810049 — PEDICAT* (April 21, 1981)
  • K810050 — VECAFIX* (March 26, 1981)
  • K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (October 31, 1980)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)
  • K802017 — DRESSING CHANGE SET CAT.#910-930 (October 10, 1980)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
  • K802016 — EYE APPLICATORS CAT.#980-983 (September 16, 1980)
  • K802001 — LAP SPONGES CAT.#801-850 (September 16, 1980)
  • K801991 — PLASTIC FORCEPS CAT.#1001-1010 (September 16, 1980)
  • K802022 — STERILE GUAZE SWABS CAT.#301-420 (September 16, 1980)

Other clearances for product code HFW

  • K041332 — JOEY CLAMP OPENING TOOL (June 25, 2004)
  • K033846 — KAEN YIH UMBILICAL CORD CLAMP (March 11, 2004)
  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K021055 — BUSSE UMBILICAL CORD CLAMP CUTTER (April 29, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K011621 — KOALA CLAMP, KOALA CLAMP AND CUTTER (August 10, 2001)
  • K010695 — KOALA CLAMP (May 3, 2001)
  • K010835 — POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLA (April 30, 2001)
  • K994367 — UMBILICAL CORD CLAMP (March 17, 2000)
  • K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (January 24, 2000)

FDA data resources