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510(k) K142163

MALE CIRCUMCISION KITS:RAPIDECLAMP by Medicfit Technology Sdn Bhd — Product Code HFX

K142163 is an FDA 510(k) premarket notification submitted by Medicfit Technology Sdn Bhd for the device "MALE CIRCUMCISION KITS:RAPIDECLAMP". The FDA issued a decision of Substantially Equivalent on April 20, 2015. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2015
Date Received
August 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code HFX

  • K251687 — Konig Bell Circumcision Clamp (February 25, 2026)
  • K221356 — Wee Bell (February 2, 2023)
  • K212911 — Konig Mogen Clamp (November 18, 2022)
  • K151095 — Circumplast Circumcision Device (September 18, 2015)
  • K131373 — SHANGRING (June 25, 2013)
  • K121789 — SHANGRING (August 3, 2012)
  • K103695 — PREPEX SYSTEM (January 10, 2012)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)
  • K063429 — GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (January 17, 2007)

FDA data resources