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510(k) K935697

CIRCUMCISION TRAY by Cush Medical Products — Product Code HFX

K935697 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "CIRCUMCISION TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on May 2, 1994. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Cush Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
May 2, 1994
Date Received
November 30, 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 Cush Medical Products

  • K943424 — CUSH ISLAND DRESSING (October 3, 1994)
  • K940518 — C-SECTION TRAY (August 18, 1994)
  • K941349 — DENTAL TRAY (July 26, 1994)
  • K941645 — BIOPSY TRAY (July 14, 1994)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K941455 — STERILE GAUZE PRODUCT LINE (May 20, 1994)
  • K941344 — LAP SPONGE PRODUCT LINE (May 12, 1994)
  • K941522 — STERILE X-RAY DETECTABLE GAUZE SPONGES (May 12, 1994)
  • K936120 — LABOR AND DELIVERY TRAY (March 30, 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