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510(k) K100916

MEDICON MOGEN CLAMP by Medicon EG — Product Code HFX

K100916 is an FDA 510(k) premarket notification submitted by Medicon EG for the device "MEDICON MOGEN CLAMP". The FDA issued a decision of Substantially Equivalent on December 6, 2010. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Medicon EG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2010
Date Received
April 2, 2010
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 by Medicon EG

  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K083803 — FIXIT HEADREST CLAMP SYSTEM (March 10, 2010)
  • K053624 — MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM (July 17, 2006)
  • K050478 — MEDICON IMF-ORION SCREWS (June 15, 2005)
  • K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM (February 23, 2005)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041527 — AARHUS ANCHORAGE SYSTEM (August 19, 2004)
  • K010908 — MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (August 1, 2001)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • K972857 — SERVOTRONIC EC100 SYSTEM (January 16, 1998)

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)
  • K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP (April 20, 2015)
  • K131373 — SHANGRING (June 25, 2013)
  • K121789 — SHANGRING (August 3, 2012)
  • K103695 — PREPEX SYSTEM (January 10, 2012)
  • 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