SILKRO
Electrosurgical, Cutting & Coagulation & Accessories
Hironic Co., Ltd
The following data is part of a premarket notification filed by Hironic Co., Ltd with the FDA for Silkro.
Pre-market Notification Details
| Device ID | K210084 |
| 510k Number | K210084 |
| Device Name: | SILKRO |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Hironic Co., Ltd 19F, 767, Sinsu-Ro, Suji-Gu Yongin-Si, KR 16827 |
| Contact | Ji Yeong Seo |
| Correspondent | Sanghwa Myung E&M D-1474, 230, Simin-daero, Dongan-gu Anyang, KR 14067 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-12 |
| Decision Date | 2022-06-03 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800016213027 | K210084 | 000 |
Trademark Results [SILKRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SILKRO 97148122 not registered Live/Pending |
HIRONIC CO., LTD. 2021-11-30 |
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