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510(k) K063151

HUMAPEN LUXURA HD by Eli Lilly and Co. — Product Code NSC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2007
Date Received
October 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Pen
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

Other clearances by Eli Lilly and Co.

  • K212217 — Tempo Smart Button (September 16, 2022)
  • K160949 — Go Dose System (December 22, 2016)
  • K142518 — HumaPen Luxura (June 5, 2015)
  • K100988 — HUMAPEN LUXURA HD (August 17, 2010)
  • K053563 — HUMAPEN MEMOIR (April 7, 2006)
  • K982842 — HUMAPEN AND HUMAPEN ERGO (September 25, 1998)