The following data is part of a premarket notification filed by Otu Medical Inc. with the FDA for Wiscope Digital Endoscope System.
| Device ID | K181977 |
| 510k Number | K181977 |
| Device Name: | WiScope Digital Endoscope System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | OTU Medical Inc. 2231A Fortune Drive San Jose, CA 95131 |
| Contact | Doris Dong |
| Correspondent | David Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-24 |
| Decision Date | 2018-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972084140054 | K181977 | 000 |
| 00850023925107 | K181977 | 000 |
| 00850023925091 | K181977 | 000 |
| 00850023925084 | K181977 | 000 |
| 10850023925074 | K181977 | 000 |
| 10850023925067 | K181977 | 000 |
| 10850023925050 | K181977 | 000 |
| 10850023925043 | K181977 | 000 |
| 10850023925029 | K181977 | 000 |
| 10850023925036 | K181977 | 000 |
| 00850023925015 | K181977 | 000 |
| 00850023925282 | K181977 | 000 |
| 10850023925333 | K181977 | 000 |
| 00850023925114 | K181977 | 000 |
| 10850023925128 | K181977 | 000 |
| 16972084140044 | K181977 | 000 |
| 16972084140037 | K181977 | 000 |
| 16972084140020 | K181977 | 000 |
| 06972084140016 | K181977 | 000 |
| 16972084140105 | K181977 | 000 |
| 16972084140099 | K181977 | 000 |
| 06972084140085 | K181977 | 000 |
| 16972084140075 | K181977 | 000 |
| 06972084140061 | K181977 | 000 |
| 10850023925159 | K181977 | 000 |
| 00850023925145 | K181977 | 000 |
| 00850023925138 | K181977 | 000 |
| 10850023925326 | K181977 | 000 |