Cleared Traditional

K050797 - TISSU-TRANS

K050797 is an FDA 510(k) clearance for TISSU-TRANS, manufactured by Shippert Medical Technologies Corp.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K050797 · Shippert Medical Technologies Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
106d
Days
Class 1
Risk

K050797 is an FDA 510(k) clearance for the TISSU-TRANS. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Shippert Medical Technologies Corp. (Centennial, US). The FDA issued a Cleared decision on July 13, 2005 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shippert Medical Technologies Corp. devices

FDA 510(k) Submission Details - K050797

510(k) Number K050797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYZ Syringe, Irrigating (non Dental)

All 15
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K050797.
OtoSet- Ear Cleaning System
K201877 · Safkan, Inc. · Nov 2020
SINGLE CANNULA EXTENDED APPLICATOR
K102563 · Micromedics, Inc. · Mar 2011
RMI DUAL FLUID IRRIGATING SYRINGE
K964833 · Research Medical, Inc. · Feb 1997
SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
K940371 · Micromedics, Inc. · Apr 1994
WELCH ALLYN EARCLEANER
K931946 · Welch Allyn, Inc. · Jul 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993