EW-10 and EW-20
FDA 510(k) K915402 · Olympus Corp.
510(k) numberK915402
Submission
- Device name
- EW-10 and EW-20
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- December 4, 1991
- Decision date
- June 23, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/DisinfectorFEB · Traditional | Wassenburg Medical, Inc. | 12/19/2024SE |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB · Special | STERIS Corporation | 12/02/2024SE |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB · Traditional | STERIS Corporation | 06/30/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | Medivators, Inc. | 01/14/2022SE |
| K201920 | Endoscope Reprocessor OER-EliteFEB · Special | Olympus Medical Systems Corp. | 09/01/2020SE |
| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | Custom Ultrasonics, Inc. | 03/30/2020SE |
| K190969 | ENDOSCOPE REPROCESSOR OER-EliteFEB · Traditional | Olympus Medical Systems Corp. | 07/09/2019SE |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB · Traditional | Advanced Sterilization Products (Asp) | 04/23/2019SE |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB · Traditional | STERIS Corporation | 12/14/2018SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | Medivators, Inc. | 12/19/2017SE |
More from Medivators, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072643 | Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/USKZN · Traditional | 11/16/2007SE |
| K043128 | Olympus EndoarmGWG · Traditional | 12/21/2004SE |
| K042140 | Olympus BF Type UC160-OL8ODG · Traditional | 08/18/2004SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | 07/01/2004SE |
| K040940 | Bronchovideoscope Olympus XBF-D160HMEOQ · Traditional | 04/19/2004SE |
| K933200 | Olympus PBD StentsFGE · Traditional | 04/05/1995SE |
| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
| K931764 | HF Resection Electrode, Loop W/Runner Hyster/AccesHIH · Traditional | 06/08/1994SE |
Questions and answers
When was EW-10 and EW-20 cleared by the FDA?
EW-10 and EW-20 (K915402) received a 510(k) decision of Substantially Equivalent for Some Indications on June 23, 1995, 1,297 days after the submission was received.
What is the product code of K915402?
The FDA product code is FEB – Accessories, Cleaning, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.