JXY · Jig, Piston Cutting, Ent, Sterile
Ear, Nose, Throat · 21 CFR 874.3540 · Class 1
Overview
| Product Code | JXY |
|---|---|
| Device Name | Jig, Piston Cutting, Ent, Sterile |
| Regulation | 21 CFR 874.3540 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTM punch; wire cutting scissors; and ossicular finger vise.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
