The following data is part of a premarket notification filed by Steris Corporation with the FDA for Acu-sinq Complete Endoscope Cleaning Aid System.
| Device ID | K181865 |
| 510k Number | K181865 |
| Device Name: | Acu-sInQ Complete Endoscope Cleaning Aid System |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Gregory Land |
| Correspondent | Gregory Land STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995168346 | K181865 | 000 |
| 00724995167783 | K181865 | 000 |
| 00724995167776 | K181865 | 000 |
| 00724995167769 | K181865 | 000 |
| 00724995167745 | K181865 | 000 |
| 00724995201791 | K181865 | 000 |
| 00724995201784 | K181865 | 000 |
| 00724995201777 | K181865 | 000 |