FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InstruSafe(R) Sterilization Container
K Number: K180528
·
Decision Nov 16, 2018
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
- InstruSafe(R) Sterilization Container
- K Number
- K180528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical, Inc.
- Date Received
- February 28, 2018
- Decision Date
- November 16, 2018
- 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 Summit Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162046 | MINNE TIES MMF Suture System | Apr 11, 2017 | Substantially Equivalent |
| K151166 | Instru-Safe Instrument Protection System | Aug 18, 2015 | Substantially Equivalent |
| K150540 | Instru-Safe Instrument Protection System | Jun 22, 2015 | Substantially Equivalent |
| K142768 | Instru-Safe Instrument Protection System | May 29, 2015 | Substantially Equivalent |
| K142630 | Instru-Safe Instrument Protection System | Dec 23, 2014 | Substantially Equivalent |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Dec 15, 2014 | Substantially Equivalent |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Jun 27, 2014 | Substantially Equivalent |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Mar 13, 2014 | Substantially Equivalent |