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510(k) K983204

HARWILL MEDICAL U-KLIP UMBILICAL CLAMP by Harwill Medical (Pty) , Ltd. — Product Code HFW

K983204 is an FDA 510(k) premarket notification submitted by Harwill Medical (Pty) , Ltd. for the device "HARWILL MEDICAL U-KLIP UMBILICAL CLAMP". The FDA issued a decision of Substantially Equivalent on February 26, 1999. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Harwill Medical (Pty) , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1999
Date Received
September 14, 1998
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 Harwill Medical (Pty) , Ltd.

  • K992618 — RESPALERT (October 29, 1999)
  • K983202 — HARWILL MEDICAL CERVITULA CERVICAL SPATULA (March 15, 1999)
  • K980550 — WHISTLE WATCH (August 27, 1998)

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