FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
UCS-2, ULTRASONIC CLEANING SOLUTION
K Number: K861147
·
Decision Jun 23, 1986
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
18
Applicant Total
29
Review Days
89
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
- UCS-2, ULTRASONIC CLEANING SOLUTION
- K Number
- K861147
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Keymed, Inc.
- Date Received
- March 26, 1986
- Decision Date
- June 23, 1986
- Product Code
- FLG
- 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 |
|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLG), ordered by most recent decision date.
KLENZYME
FDA 510(k)
FDA Class 1
·General Hospital
ALSA-KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
BILL EVANS-KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
MON-KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
NPH-KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
INSTRU KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Keymed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Apr 22, 2010 | Substantially Equivalent |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Mar 29, 1993 | Substantially Equivalent |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | May 12, 1988 | Substantially Equivalent |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Feb 12, 1987 | Substantially Equivalent |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | Dec 24, 1986 | Substantially Equivalent |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Aug 12, 1986 | Substantially Equivalent |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Jul 15, 1986 | Substantially Equivalent |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | Jun 17, 1986 | Substantially Equivalent |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Nov 26, 1985 | Substantially Equivalent |
| K854304 | KEYMED OFFICE COUCH | Nov 12, 1985 | Substantially Equivalent |