FLG · Cleaner, Ultrasonic, Medical Instrument
General Hospital · 21 CFR 880.6150 · Class 1
Overview
| Product Code | FLG |
|---|---|
| Device Name | Cleaner, Ultrasonic, Medical Instrument |
| Regulation | 21 CFR 880.6150 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.
Classification Rationale
Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944950 | KLENZYME | Calgon Corp. | Dec 20, 1994 | SESE |
| K944494 | ALSA-KLENZ | Calgon Vestal Div. | Oct 19, 1994 | SESE |
| K944033 | BILL EVANS-KLENZ | Calgon Vestal Div. | Oct 7, 1994 | SESE |
| K941163 | MON-KLENZ | Calgon Vestal Div. | May 18, 1994 | SESE |
| K940263 | NPH-KLENZ | Calgon Corp. | May 18, 1994 | SESE |
| K935063 | INSTRU KLENZ | Calgon Corp. | May 9, 1994 | SESE |
| K934666 | PDS ULTRACLEAN | Medical Polymers, Inc. | Apr 15, 1994 | SESE |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Surgicot, Inc. | Apr 13, 1994 | SESE |
| K933149 | INSTRUMENT DETERGENT CONCENTRATE | Nobelpharma USA, Inc. | Feb 16, 1994 | SESE |
| K884660 | BIOSONIC ULTRASONIC CLEANING SYSTEM | Whaledent Intl. Div. Ipco | Mar 16, 1989 | SESE |
| K862282 | RAPIDEX BIOLOGICAL SURFACTANT | Rapidex of London | May 11, 1987 | SESE |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Keymed, Inc. | Jun 23, 1986 | SESE |
| K861592 | WEC-WASH, CATALOG NO. 850-115 | Palmetto Chemical & Supply Co., Inc. | Jun 17, 1986 | SESE |
| K861590 | WEC-KLEEN, CATALOG N. 850-102 | Palmetto Chemical & Supply Co., Inc. | Jun 17, 1986 | SESE |
| K861588 | WECK INSTRUMENT CLEANER, CAT. NO. 850-103 | Palmetto Chemical & Supply Co., Inc. | Jun 17, 1986 | SESE |
| K861587 | WECK CONCENTRATED LIQUID CLEANER | Palmetto Chemical & Supply Co., Inc. | May 19, 1986 | SESE |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | Spelna, Inc. | Jan 3, 1986 | SESE |
| K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | Custom Ultrasonics | Nov 28, 1984 | SESE |
| K771679 | MICROFLATOR | Fisons Corp. | Sep 28, 1977 | SESE |
Top Applicants
- Palmetto Chemical & Supply Co., Inc. — 4 clearances
- Calgon Corp. — 3 clearances
- Calgon Vestal Div. — 3 clearances
- Custom Ultrasonics — 1 clearance
- Fisons Corp. — 1 clearance
