Definition: FDA Has Exempted These Devices From The Premarket Notification Requirement By Publishing In The Federal Register Of July 11, 2017 (82 FR 31976) Available At Https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-fr
| Device Type ID | 5406 |
| Device Name | Biopsy Needle Guide Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Regulation Description | Ultrasonic Pulsed Echo Imaging System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 892.1560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5406 |
| Device | Biopsy Needle Guide Kit |
| Product Code | OIJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Pulsed Echo Imaging System. |
| CFR Regulation Number | 892.1560 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 1 |
Break | 1 |
Handpiece | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Devicor Medical Products Inc | II | Jul-14-2016 |
| 2 | Hologic, Inc. | II | Jan-14-2018 |