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510(k) K131617

COLONGLIDE(R) LUBRICANT by Pediatric Pharmaceuticals, Inc. — Product Code KMJ

K131617 is an FDA 510(k) premarket notification submitted by Pediatric Pharmaceuticals, Inc. for the device "COLONGLIDE(R) LUBRICANT". The FDA issued a decision of Substantially Equivalent on October 3, 2013. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Pediatric Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2013
Date Received
June 3, 2013
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 Pediatric Pharmaceuticals, Inc.

  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)

Other clearances for product code KMJ

  • K142473 — Lubricating Jelly (April 13, 2015)
  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)
  • 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)
  • K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (May 22, 2008)

FDA data resources