21 CFR 874.3540 — Block, Cutting, Ent, Sterile
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3540
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JXS | Block, Cutting, Ent, Sterile | 1 | 2 | |
| JXT | Crimper, Wire, Ent, Sterile | 1 | 0 | |
| JXW | Die, Wire Bending, Ent, Sterile | 1 | 0 | |
| JXX | Forceps, Wire Closure, Ent, Sterile | 1 | 0 | |
| JXY | Jig, Piston Cutting, Ent, Sterile | 1 | 0 | |
| JXZ | Punch, Gelfoam, Sterile | 1 | 0 | |
| JYA | Scissors, Wire Cutting, Ent, Sterile | 1 | 0 | |
| JYB | Vise, Ossicular Finger, Sterile | 1 | 0 | |
| LRE | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile | 1 | 0 | |
| NNN | Crimper, Wire, Ent, Non-Sterile | 1 | 0 | |
| NNO | Jig, Piston Cutting, Ent, Non-Sterile | 1 | 0 | |
| NNP | Die, Wire Bending, Ent, Non-Sterile | 1 | 0 | |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | 1 | 0 | |
| NNR | Block, Cutting, Ent, Non-Sterile | 1 | 0 | |
| NNS | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile | 1 | 0 | |
| NNT | Punch, Gelfoam, Non-Sterile | 1 | 0 | |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | 1 | 0 | |
| NNV | Vise, Ossicular Finger, Non-Sterile | 1 | 0 |
