Monopolar Hook
510(k) K203603
Monopolar Hook is a Class II device made by Human Xtensions, Ltd., cleared under FDA 510(k) K203603 on 1 Feb 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203603 | Date1 Feb 2021 | StatusActive |
Official records
- FDA 510(k) database K203603
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GCJ
- FDA applicant
- Human Xtensions , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203603
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Monopolar Hook 20-30-044-01 | 20-30-073-01 / 20-30-044-01 | 07290017376080 | — | On the market |
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