The following data is part of a premarket notification filed by Human Xtensions Ltd. with the FDA for Monopolar Hook.
| Device ID | K203603 |
| 510k Number | K203603 |
| Device Name: | Monopolar Hook |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Human Xtensions Ltd. Meir Ariel 4 Netanya, IL 4250574 |
| Contact | Maija Wallenstein |
| Correspondent | Randy J. Prebula Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-09 |
| Decision Date | 2021-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017376080 | K203603 | 000 |