JEJ · Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
Ear, Nose, Throat · 21 CFR 874.4680 · Class 2
Overview
| Product Code | JEJ |
|---|---|
| Device Name | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874705 | EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 | Em Diagnostic Systems, Inc. | Dec 22, 1987 | SESE |
| K821514 | TECHNICON RA-1000 SYS, ANALYTES III | Technicon Instruments Corp. | May 10, 1982 | SESE |
Top Applicants
- Technicon Instruments Corp. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
