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510(k) K894397

WELCON LIGHT HANDLE by Welcon, Inc. — Product Code FTA

K894397 is an FDA 510(k) premarket notification submitted by Welcon, Inc. for the device "WELCON LIGHT HANDLE". The FDA issued a decision of Substantially Equivalent on August 10, 1989. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Welcon, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Welcon, Inc.

  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K912869 — WOMEN AND INFANT'S DELIVERY PACK (December 4, 1991)
  • K904158 — ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY (November 29, 1990)
  • K830359 — STERILE CATHERIZATION PROCEDURE TRAYS (March 17, 1983)
  • K813027 — STERILE IRRIGATING SYRINGES, KITS,TRAY (November 20, 1981)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)

FDA data resources