Home / 510(k) Clearances / K080042

510(k) K080042

SPIRUS MEDICAL SURGICAL INSTRUMENT by Spirus Medical, Inc. — Product Code KMJ

K080042 is an FDA 510(k) premarket notification submitted by Spirus Medical, Inc. for the device "SPIRUS MEDICAL SURGICAL INSTRUMENT". The FDA issued a decision of Substantially Equivalent on April 3, 2008. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Spirus Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2008
Date Received
January 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Patient
Device Class
Class I
Regulation Number
880.6375
Review Panel
HO
Submission Type

Other clearances by Spirus Medical, Inc.

  • K080050 — SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE (May 6, 2008)
  • K062805 — MODIFICATION TO ENDO-EASE (October 13, 2006)
  • K060235 — ENDO-EASE ENDOSCOPIC OVERTUBE (August 4, 2006)
  • K052084 — ENDO-EASE ENDOSCOPIC OVERTUBE (September 14, 2005)

Other clearances for product code KMJ

  • K142473 — Lubricating Jelly (April 13, 2015)
  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)
  • K131617 — COLONGLIDE(R) LUBRICANT (October 3, 2013)
  • K121390 — LUBE JELLY SURINGE (August 10, 2012)
  • K113689 — DUKAL LUBRICATING JELLY (May 4, 2012)
  • K112110 — STERILE LUBRICATING JELLY (April 10, 2012)
  • K103718 — DYNACOR LUBRICATION GEL (May 10, 2011)
  • K101522 — ULTRA SEAL STERILE LUBRICATING JELLY (December 23, 2010)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)

FDA data resources