← FDA Medical Device Classifications
Block, Cutting, Ent, Non-Sterile
NNR · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.3540
Classification
- FDA Product Code
NNR- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 874.3540
- Review panel
- EN
- Medical specialty
- Ear, Nose, Throat
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Prosthesis modification instrument for ossicular replacement surgery; see product code JXS.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 37
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown