FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAVOKLAVE STEAM AUTOCLAVE
K Number: K910789
·
Decision Aug 26, 1991
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
20
Review Days
182
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
- KAVOKLAVE STEAM AUTOCLAVE
- K Number
- K910789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kavo America
- Date Received
- February 25, 1991
- Decision Date
- August 26, 1991
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLE), ordered by most recent decision date.
Enbio PRO
FDA 510(k)
FDA Class 2
·General Hospital
Getinge GSS67N Series Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
Cassette Autoclave (ACA5)
FDA 510(k)
FDA Class 2
·General Hospital
Steam Sterilizer (2545D)
FDA 510(k)
FDA Class 2
·General Hospital
FRONT-LINE Field Sterilizer (FL135)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Kavo America
| K Number | Device Name | ||
|---|---|---|---|
| K073074 | KEY LASER III 1243 US WITH DETECT | Jul 10, 2008 | Substantially Equivalent |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | Oct 26, 2007 | Substantially Equivalent |
| K063624 | KAVO EVEREST C-TEMP | Feb 8, 2007 | Substantially Equivalent |
| K051909 | DIAGNODENT | Oct 21, 2005 | Substantially Equivalent |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | Aug 3, 2005 | Substantially Equivalent |
| K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | Jan 31, 2005 | Substantially Equivalent |
| K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 | Jul 24, 2003 | Substantially Equivalent |
| K031868 | PROPHYPEARLS | Jul 9, 2003 | Substantially Equivalent |
| K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES | May 2, 2003 | Substantially Equivalent |
| K024214 | KAVO EVEREST TITANBLANK | Mar 12, 2003 | Substantially Equivalent |