BWB · Forceps, Tube Introduction
Anesthesiology · 21 CFR 868.5780 · Class 1
Overview
| Product Code | BWB |
|---|---|
| Device Name | Forceps, Tube Introduction |
| Regulation | 21 CFR 868.5780 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.
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 the limitations in § 868.9.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884584 | TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS | Eastmed Enterprises, Inc. | Nov 14, 1988 | SESE |
| K880319 | MAGILL FORCEPS | Eastmed Enterprises, Inc. | Mar 21, 1988 | SESE |
| K880318 | ROVENSTEIN FORCEPS | Eastmed Enterprises, Inc. | Mar 21, 1988 | SESE |
| K840313 | CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV | Imm Enterprises , Ltd. | Feb 4, 1984 | SESE |
| K834169 | OP-CON SURGICAL INSTRUMENT #9 | Imm Enterprises , Ltd. | Jan 17, 1984 | SESE |
| K820451 | INTRODUCER FOR ENDOTRACHEAL TUBE | Imed Corp. | Mar 26, 1982 | SESE |
Top Applicants
- Eastmed Enterprises, Inc. — 3 clearances
- Imm Enterprises , Ltd. — 2 clearances
- Imed Corp. — 1 clearance
