Cleaner, Ultrasonic, Medical Instrument
The Medical Instrument Ultrasonic Cleaner is a device that uses ultrasonic energy to remove debris and contaminants from surgical instruments and medical devices prior to sterilization or disinfection. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FLG, regulated under 21 CFR 880.6150 in the General Hospital specialty.
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Basic Information
- Product Code
- FLG
- Device Class
- FDA class 1
- Regulation Number
- 880.6150
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944950 | KLENZYME | Dec 20, 1994 | Substantially Equivalent | Calgon Corp. |
| K944494 | ALSA-KLENZ | Oct 19, 1994 | Substantially Equivalent | Calgon Vestal Div. |
| K944033 | BILL EVANS-KLENZ | Oct 07, 1994 | Substantially Equivalent | Calgon Vestal Div. |
| K941163 | MON-KLENZ | May 18, 1994 | Substantially Equivalent | Calgon Vestal Div. |
| K940263 | NPH-KLENZ | May 18, 1994 | Substantially Equivalent | Calgon Corp. |
| K935063 | INSTRU KLENZ | May 09, 1994 | Substantially Equivalent | Calgon Corp. |
| K934666 | PDS ULTRACLEAN | Apr 15, 1994 | Substantially Equivalent | Medical Polymers, Inc. |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Apr 13, 1994 | Substantially Equivalent | Surgicot, Inc. |
| K933149 | INSTRUMENT DETERGENT CONCENTRATE | Feb 16, 1994 | Substantially Equivalent | Nobelpharma USA, Inc. |
| K884660 | BIOSONIC ULTRASONIC CLEANING SYSTEM | Mar 16, 1989 | Substantially Equivalent | Whaledent Intl. Div. Ipco |
| K862282 | RAPIDEX BIOLOGICAL SURFACTANT | May 11, 1987 | Substantially Equivalent | Rapidex of London |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Jun 23, 1986 | Substantially Equivalent | Keymed, Inc. |
| K861592 | WEC-WASH, CATALOG NO. 850-115 | Jun 17, 1986 | Substantially Equivalent | Palmetto Chemical & Supply Co., Inc. |
| K861590 | WEC-KLEEN, CATALOG N. 850-102 | Jun 17, 1986 | Substantially Equivalent | Palmetto Chemical & Supply Co., Inc. |
| K861588 | WECK INSTRUMENT CLEANER, CAT. NO. 850-103 | Jun 17, 1986 | Substantially Equivalent | Palmetto Chemical & Supply Co., Inc. |
| K861587 | WECK CONCENTRATED LIQUID CLEANER | May 19, 1986 | Substantially Equivalent | Palmetto Chemical & Supply Co., Inc. |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | Jan 03, 1986 | Substantially Equivalent | Spelna, Inc. |
| K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | Nov 28, 1984 | Substantially Equivalent | Custom Ultrasonics |
| K771679 | MICROFLATOR | Sep 28, 1977 | Substantially Equivalent | Fisons Corp. |
FEI Numbers
This FDA classification entry is associated with 150 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 150 registration numbers. Click on an entry to view related FDA registrations.