Cleared Traditional

UROSURGE UROTHERM FLUID WARMING SYSTEM

K965136 · Princeton Regulatory Assoc. · General Hospital

Oct 1998

Decision

662d

Days

Class 1

Risk

About This 510(k) Submission

K965136 is an FDA 510(k) clearance for the UROSURGE UROTHERM FLUID WARMING SYSTEM, a Warmer, Irrigation Solution (Class I — General Controls, product code LHC), submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on October 16, 1998, 662 days after receiving the submission on December 23, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K965136 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1996
Decision Date	October 16, 1998
Days to Decision	662 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement