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510(k) K013040

LIGHT SABER INTRODUCER NEEDLE by Minrad, Inc. — Product Code MDM

K013040 is an FDA 510(k) premarket notification submitted by Minrad, Inc. for the device "LIGHT SABER INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on December 7, 2001. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Minrad, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2001
Date Received
September 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Minrad, Inc.

  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)
  • K071814 — LIGHT SABRE SPINAL ACCESS DEVICE (October 16, 2007)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K041846 — SABRESOURCE DRAPE (August 26, 2004)
  • K021084 — LIGHT SABER SPINAL NEEDLE (July 3, 2002)
  • K982735 — LIGHT SABER BONE BIOPSY NEEDLE (September 9, 1998)
  • K982018 — LIGHT SABER ASPIRATION NEEDLE (August 7, 1998)
  • K981796 — LIGHT SABER CORE TISSUE NEEDLE (August 5, 1998)

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (August 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)
  • K945430 — DERMAVBLADE(TM) (November 28, 1994)

FDA data resources