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510(k) K963428

UMBILICAL CLAMP AND CUTTER by R.O.S.T. Medical Development, Inc. — Product Code HFW

K963428 is an FDA 510(k) premarket notification submitted by R.O.S.T. Medical Development, Inc. for the device "UMBILICAL CLAMP AND CUTTER". The FDA issued a decision of Substantially Equivalent on April 1, 1997. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1997
Date Received
August 30, 1996
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 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)
  • K000227 — UMBICUT (April 27, 2000)
  • K994367 — UMBILICAL CORD CLAMP (March 17, 2000)

FDA data resources