Curette, Biopsy, Bronchoscope (Rigid)
FDA product code JEL · Class II (moderate risk) · 21 CFR 874.4680 · Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932853 | Pin Holders, Transfixing Pins, Ol Wires, Half PinsJEL · Traditional | Applied Osteo Systems, Inc. | 02/22/1994SE |