Home / 510(k) Clearances / K965136

510(k) K965136

UROSURGE UROTHERM FLUID WARMING SYSTEM by Princeton Regulatory Assoc. — Product Code LHC

K965136 is an FDA 510(k) premarket notification submitted by Princeton Regulatory Assoc. for the device "UROSURGE UROTHERM FLUID WARMING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Princeton Regulatory Assoc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1998
Date Received
December 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by Princeton Regulatory Assoc.

  • K972158 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (February 20, 1998)
  • K973504 — UROSURGE UROSTENT (January 30, 1998)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)

Other clearances for product code LHC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)

FDA data resources