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510(k) K020304

DISPOSABLE LIGHT HANDLE AND ADAPTOR by Aspen Surgical Products, Inc. — Product Code FTA

K020304 is an FDA 510(k) premarket notification submitted by Aspen Surgical Products, Inc. for the device "DISPOSABLE LIGHT HANDLE AND ADAPTOR". The FDA issued a decision of Substantially Equivalent on February 14, 2002. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Aspen Surgical Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2002
Date Received
January 29, 2002
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 Aspen Surgical Products, Inc.

  • K030339 — CAUTERY TIP CLEANER, MODEL-TC-100 (March 7, 2003)

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