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510(k) K043533

SURGICAL DESIGN CIRCUMCISION CLAMP by Surgical Design, Inc. — Product Code HFX

K043533 is an FDA 510(k) premarket notification submitted by Surgical Design, Inc. for the device "SURGICAL DESIGN CIRCUMCISION CLAMP". The FDA issued a decision of Substantially Equivalent on April 1, 2005. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Surgical Design, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2005
Date Received
December 22, 2004
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 Surgical Design, Inc.

  • K991852 — OCUSYSTEM ART ADVANTAGE, MODEL 995 (July 7, 1999)
  • K961243 — OCUSYSTEM ART ADVANTAGE (July 10, 1996)
  • K934817 — SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS (June 17, 1994)

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)

FDA data resources