FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
ST-Z5
K Number: K201878
·
Decision Mar 25, 2021
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
9
Review Days
261
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ST-Z5
- K Number
- K201878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Z-Systems AG
- Date Received
- July 7, 2020
- Decision Date
- March 25, 2021
- Product Code
- KCT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCT), ordered by most recent decision date.
SteriBest® Sterilization Tray System
FDA 510(k)
FDA Class 2
·General Hospital
SteriTite Container System with MediTray Products
FDA 510(k)
FDA Class 2
·General Hospital
Straumann® ProClean Cassette (041.800 ; 041.801)
FDA 510(k)
FDA Class 2
·General Hospital
PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
FDA 510(k)
FDA Class 2
·General Hospital
Stainless Steel Surgical Kits
FDA 510(k)
FDA Class 2
·General Hospital
Sterilization Trays
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Z-Systems AG
| K Number | Device Name | ||
|---|---|---|---|
| K201712 | Z5-TL | Dec 1, 2020 | Substantially Equivalent |
| K200386 | Z5-BL | Oct 14, 2020 | Substantially Equivalent |
| K190243 | Z5-BL | Jan 3, 2020 | Substantially Equivalent |
| K150021 | Z5m(t) | Jul 31, 2015 | Substantially Equivalent |
| K132881 | Z5C | Jul 3, 2014 | Substantially Equivalent |
| K131701 | Z5MLB, Z5MLC | Sep 5, 2013 | Substantially Equivalent |
| K120793 | Z-LOOK3 EVO SLM | Dec 21, 2012 | Substantially Equivalent |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | Oct 29, 2007 | Substantially Equivalent |