Home / 510(k) Clearances / K945949

510(k) K945949

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] by Vlm Surgical, Inc. — Product Code HFX

K945949 is an FDA 510(k) premarket notification submitted by Vlm Surgical, Inc. for the device "KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]". The FDA issued a decision of Substantially Equivalent on July 25, 1995. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Vlm Surgical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
December 6, 1994
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 Vlm Surgical, Inc.

  • K842912 — THE SUTURER (August 15, 1984)

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