PathKeeper System
510(k) K222355
PathKeeper System is a Class II device made by Pathkeeper Surgical Ltd, cleared under FDA 510(k) K222355 on 8 Mar 2023, 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 | NumberK222355 | Date8 Mar 2023 | StatusActive |
Official records
- FDA 510(k) database K222355
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- FDA applicant
- Pathkeeper Surgical , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K222355
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 | |||
|---|---|---|---|---|
| PathKeeper Software PSW0001-01 | PSW0001-01 | 07290019120148 | On the market | |
| PathKeeper Surgical Accessories Kit KIT0002 | KIT0002 | 07290019120339 | On the market | |
| PathKeeper Surgical Accessories Kit KIT0002-01 | KIT0002-01 | 07290019120001 | On the market | |
| PathKeeper System TPL0001-01 | TPL0001-01 | 07290019120094 | On the market | |
| PKS Accessories Setup DRF MAS0001 | MAS0001 | 07290019120179 | On the market | |
| PKS Accessories Setup DRF MAS0001-01 | MAS0001-01 | 07290019120018 | On the market | |
| PKS DRF 2 - ID 5.9 MAS0003 | MAS0003 | 07290019120353 | On the market | |
| PKS DRF 2-ID5.9 MAS0003 | MAS0003 | 07290019120216 | No longer on the market | |
| PKS DRF 2-ID5.9 MAS0003-01 | MAS0003-01 | 07290019120032 | On the market | |
| PKS DRF 2-ID6.9 MAS0004 | MAS0004 | 07290019120230 | No longer on the market | |
| PKS DRF 2-ID6.9 MAS0004-01 | MAS0004-01 | 07290019120049 | On the market | |
| PKS DRF 3 - ID 12.2 MAS0007 | MAS0007 | 07290019120377 | On the market | |
| PKS DRF 3-ID12.2 MAS0007 | MAS0007 | 07290019120292 | No longer on the market | |
| PKS DRF 3-ID12.2 MAS0007-01 | MAS0007-01 | 07290019120070 | On the market | |
| PKS DRF 3-ID15 MAS0008 | MAS0008 | 07290019120315 | On the market | |
| PKS DRF 3-ID15 MAS0008-01 | MAS0008-01 | 07290019120087 | On the market | |
| PKS DRF 4 - ID 7.9 MAS0005 | MAS0005 | 07290019120360 | On the market | |
| PKS DRF 4-ID7.9 MAS0005 | MAS0005 | 07290019120254 | No longer on the market | |
| PKS DRF 4-ID7.9 MAS0005-01 | MAS0005-01 | 07290019120056 | On the market | |
| PKS DRF 4-ID9.5x8 MAS0006 | MAS0006 | 07290019120278 | On the market | |
| PKS DRF 4-ID9.5x8 MAS0006-01 | MAS0006-01 | 07290019120063 | On the market | |
| PKS Patient Reference DRF MAS0002 | MAS0002 | 07290019120193 | No longer on the market | |
| PKS Patient Reference DRF MAS0002 | MAS0002 | 07290019120346 | On the market | |
| PKS Patient Reference DRF MAS0002-01 | MAS0002-01 | 07290019120025 | On the market | |
| S3D OTI Camera DC Power Supply CBL0001-01 | CBL0001-01 | 07290019120131 | On the market | |
| S3D OTI Camera Dongle ELP0001-01 | ELP0001-01 | 07290019120124 | On the market | |
| S3D OTI Camera EMA0001 | EMA0001 | 07290019120261 | On the market | |
| S3D OTI Camera EMA0001-01 | EMA0001-01 | 07290019120117 | On the market |
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