Cleared Traditional

K050797 - TISSU-TRANS
(FDA 510(k) Clearance)

K050797 · Shippert Medical Technologies Corp. · General Hospital
Jul 2005
Decision
106d
Days
Class 1
Risk

K050797 is an FDA 510(k) clearance for the TISSU-TRANS, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Shippert Medical Technologies Corp. (Centennial, US). The FDA issued a Cleared decision on July 13, 2005, 106 days after receiving the submission on March 29, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K050797 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2005
Decision Date July 13, 2005
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6960