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510(k) K032091

SMART KLAMP VARIOUS BY SIZE by Emergogroup, Inc. — Product Code HFX

K032091 is an FDA 510(k) premarket notification submitted by Emergogroup, Inc. for the device "SMART KLAMP VARIOUS BY SIZE". The FDA issued a decision of Substantially Equivalent on March 8, 2004. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Emergogroup, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2004
Date Received
July 7, 2003
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 Emergogroup, Inc.

  • K042917 — STAT MEDICAL PEN NEEDLE (April 22, 2005)

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