Product code FLG
- Device name
- Cleaner, Ultrasonic, Medical Instrument
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6150
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944950 | KLENZYME | Calgon Corp. | 1994-12-20 |
| K944494 | ALSA-KLENZ | Calgon Vestal Div. | 1994-10-19 |
| K944033 | BILL EVANS-KLENZ | Calgon Vestal Div. | 1994-10-07 |
| K941163 | MON-KLENZ | Calgon Vestal Div. | 1994-05-18 |
| K940263 | NPH-KLENZ | Calgon Corp. | 1994-05-18 |
| K935063 | INSTRU KLENZ | Calgon Corp. | 1994-05-09 |
| K934666 | PDS ULTRACLEAN | Medical Polymers, Inc. | 1994-04-15 |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Surgicot, Inc. | 1994-04-13 |
| K933149 | INSTRUMENT DETERGENT CONCENTRATE | Nobelpharma USA, Inc. | 1994-02-16 |
| K884660 | BIOSONIC ULTRASONIC CLEANING SYSTEM | Whaledent Intl. Div. Ipco | 1989-03-16 |
| K862282 | RAPIDEX BIOLOGICAL SURFACTANT | Rapidex of London | 1987-05-11 |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Keymed, Inc. | 1986-06-23 |
| K861592 | WEC-WASH, CATALOG NO. 850-115 | Palmetto Chemical & Supply Co., Inc. | 1986-06-17 |
| K861590 | WEC-KLEEN, CATALOG N. 850-102 | Palmetto Chemical & Supply Co., Inc. | 1986-06-17 |
| K861588 | WECK INSTRUMENT CLEANER, CAT. NO. 850-103 | Palmetto Chemical & Supply Co., Inc. | 1986-06-17 |
| K861587 | WECK CONCENTRATED LIQUID CLEANER | Palmetto Chemical & Supply Co., Inc. | 1986-05-19 |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | Spelna, Inc. | 1986-01-03 |
| K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | Custom Ultrasonics | 1984-11-28 |
| K771679 | MICROFLATOR | Fisons Corp. | 1977-09-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H816GEL121 | Spec Clean Pre Treatment Gel | MicroCare, LLC | 2025-10-23 |
| H816OP1281 | Optizyme | MicroCare, LLC | 2025-10-23 |
| H816PREZ128 | Spec Clean Dual Enzymatic Detergent | MicroCare, LLC | 2025-10-22 |
| H816VPLR32 | Spec Clean Instrument Lubricant - Vet Branded | MicroCare, LLC | 2025-10-22 |
| H816VPLC128 | Spec Clean Concentrated Instrument Lubricant - Vet Branded | MicroCare, LLC | 2025-10-22 |
| H816VEZ128 | Spec Clean Single Enzymatic Detergent Veterinary Brand | MicroCare, LLC | 2025-10-22 |
| H816PW128 | Spec Clean Instrument Cart Detergent & Cart Wash Neutral | MicroCare, LLC | 2025-10-22 |
| H816PW050 | Spec Clean Instrument Cart Detergent & Cart Wash Neutral | MicroCare, LLC | 2025-10-22 |
| H816PVAC275 | Spec Clean Evacuation System Cleaner | MicroCare, LLC | 2025-10-22 |
| H816PVAC128 | Spec Clean Evacuation System Cleaner | MicroCare, LLC | 2025-10-22 |
| H816PRR128 | Spec Clean Rinse Agent | MicroCare, LLC | 2025-10-22 |
| H816PRR050 | Spec Clean Rinse Agent | MicroCare, LLC | 2025-10-22 |
| H816PREZF240 | Spec Clean Pre Treatment Foam Spray | MicroCare, LLC | 2025-10-22 |
| H816PREZF128 | Spec Clean Pre Treatment Foam Spray | MicroCare, LLC | 2025-10-22 |
| H816PREZAW128 | Spec Clean Quad Enzymatic Detergent | MicroCare, LLC | 2025-10-22 |
| H816PREZAW050 | Spec Clean Quad Enzymatic Detergent | MicroCare, LLC | 2025-10-22 |
| H816PREZ275 | Spec Clean Dual Enzymatic Detergent | MicroCare, LLC | 2025-10-22 |
| H816PLR32 | Spec Clean Instrument Lubricant | MicroCare, LLC | 2025-10-22 |
| H816PLC128 | Spec Clean Concentrated Instrument Lubricant | MicroCare, LLC | 2025-10-22 |
| H816PCNF128 | Spec Clean Instrument Detergent Alkaline | MicroCare, LLC | 2025-10-22 |
| H816EZTAB641 | Spec Clean Enzymatic Tablets | MicroCare, LLC | 2025-10-22 |
| H816EZ128 | Spec Clean Single Enzymatic Detergent | MicroCare, LLC | 2025-10-22 |
| 08051520011993 | Steelco | STEELCO SPA | 2023-09-12 |
| H65810492070 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-18 |
| H65810167670 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-18 |
| H65810103770 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-18 |
| H65810222551 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-03 |
| H65810042501 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-03 |
| H65810041791 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-03 |
| H65810031851 | Henry Schein | HENRY SCHEIN, INC. | 2020-03-03 |