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510(k) K063429

GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 by Generic Medical Device, Inc. — Product Code HFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2007
Date Received
November 13, 2006
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 Generic Medical Device, Inc.

  • K111219 — GMD UNIVERSAL URINARY INCONTINENCE SLING (June 30, 2011)
  • K083471 — GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (March 3, 2009)
  • K070018 — UNIVERSAL SURGICAL MESH, MODEL 100 (April 27, 2007)

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)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)