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510(k) K935491

CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) by Tri-State Hospital Supply Corp. — Product Code HFX

K935491 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1994
Date Received
November 15, 1993
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 Tri-State Hospital Supply Corp.

  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K942353 — CENTURION UMBILICAL CATHETER (August 15, 1995)
  • K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING (March 29, 1995)
  • K931748 — CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS (February 25, 1994)
  • K923812 — CENTURION DISPOSABLE INSTRUMENTS (December 17, 1992)
  • K910906 — CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS (April 1, 1991)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)
  • K896320 — CENTURION KLEEN-NEEDLE SYSTEM (January 11, 1990)
  • K893647 — COPOLYESTER FILM DRESSING (October 16, 1989)

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