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510(k) K160501

Noxilizer Surgical Ruler by Noxilizer, Inc. — Product Code FTY

K160501 is an FDA 510(k) premarket notification submitted by Noxilizer, Inc. for the device "Noxilizer Surgical Ruler". The FDA issued a decision of Substantially Equivalent on May 26, 2016. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2016
Date Received
February 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Measuring, Rulers And Calipers
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code FTY

  • K951064 — DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (May 19, 1995)
  • K934930 — OLYMPIC AUTO-LENGTH (December 29, 1993)
  • K932112 — OLYMPIC INFA-LENGTH (July 22, 1993)
  • K883485 — STRYKER PRESSURE MONITOR SYSTEM (September 13, 1988)
  • K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (February 18, 1988)
  • K874352 — TUMORIMETER (November 23, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K872319 — LN 100 BREAST MARKER (August 11, 1987)
  • K863409 — KUNDIN WOUND GAUGE (September 29, 1986)
  • K862576 — PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (July 15, 1986)

FDA data resources