510(k) K222849
- Device
- AMSCO 600 Steam Sterilizer, V-PRO MaX 2 Low Temperature Sterilization System, V-PRO S2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP And 7053HP Single
- Applicant
- Steris
- 510(k) number
- K222849
- Product code
- NVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-30
- Date received
- 2022-09-21
- Regulation
- 876.1500
- Classification name
- Washer, Cleaner, Automated, Endoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anthony Piotrkowski
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3013283620
- 3005899764
- 2518897
- 3015612252
- 9680353
- 2150060
- 3001675293
Source Documents#
Other 510(k) Records For Product Code NVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | Steris | 2022-08-25 |
| K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | STERIS Corporation | 2020-12-01 |
| K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | STERIS Corporation | 2020-04-03 |
| K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | STERIS Corporation | 2019-08-21 |
| K073112 | DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 | Intuitive Surgical, Inc. | 2008-08-01 |
| K043314 | MANZI CLEANER SYSTEM | Langford IC Systems, Inc. | 2005-06-20 |
| K983017 | MODIFICATION TO SYSTEM 83 PLUS | Custom Ultrasonics | 1998-09-22 |
| K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. | Machida America, Inc. | 1988-01-14 |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Keymed, Inc. | 1987-02-12 |
| K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Medivators, Inc. | 1987-02-03 |
| K832458 | AUTOMATIC ENDOSCOPE | American Endoscopy, Inc. | 1983-10-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases