510(k) K915402
- Device
- Ew-10 And Ew-20
- Applicant
- OLYMPUS CORP.
- 510(k) number
- K915402
- Product code
- FEB
- Decision
- Substantially Equivalent for Some Indications (SN)
- Decision date
- 1995-06-23
- Date received
- 1991-12-04
- Regulation
- 876.1500
- Classification name
- Accessories, Cleaning, For Endoscope
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET CONWAY
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 9680353
- 9610849
- 3011050570
- 2150060
- 3007082252
- 3008157119
- 8010047
- 2647580
- 1220592
- 3005646850
- 1219930
- 1651395
- 1527821
- 2084725
- 1222168
- 3042172882
- 2518897
- 3000251274
- 9610595
- 3005987240
- 3003950207
- 3018094310
- 1418479
- 3024021261
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FEB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. | 2024-12-19 |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | 2024-12-02 |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023-06-30 |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Medivators, Inc. | 2022-01-14 |
| K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020-09-01 |
| K173590 | System 83 Plus Washer/Disinfector | Custom Ultrasonics, Inc. | 2020-03-30 |
| K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019-07-09 |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Advanced Sterilization Products (Asp) | 2019-04-23 |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | 2018-12-14 |
| K172677 | Advantage Plus Pass-Thru | Medivators, Inc. | 2017-12-19 |
| K162120 | Scope-Assist Flushing Sink | Custom Ultrasonics, Inc. | 2017-04-28 |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | Medivators, Inc. | 2016-12-21 |
| K152189 | EVOTECH ECR | Advanced Sterilization Products (Asp) | 2016-07-20 |
| K140977 | EVOTECH ECR | Advanced Sterilization Products | 2014-12-22 |
| K122172 | SYSTEM 83 PLUS | Custom Ultrasonics | 2013-01-25 |