Forceps, Tube Introduction
The Forceps, Tube Introduction are forceps specifically designed to grasp and guide a tracheal or tracheostomy tube into correct position within the airway during intubation procedures. They are classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BWB, regulated under 21 CFR 868.5780 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BWB
- Device Class
- FDA class 1
- Regulation Number
- 868.5780
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884584 | TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS | Nov 14, 1988 | Substantially Equivalent | Eastmed Enterprises, Inc. |
| K880319 | MAGILL FORCEPS | Mar 21, 1988 | Substantially Equivalent | Eastmed Enterprises, Inc. |
| K880318 | ROVENSTEIN FORCEPS | Mar 21, 1988 | Substantially Equivalent | Eastmed Enterprises, Inc. |
| K840313 | CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV | Feb 04, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K834169 | OP-CON SURGICAL INSTRUMENT #9 | Jan 17, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K820451 | INTRODUCER FOR ENDOTRACHEAL TUBE | Mar 26, 1982 | Substantially Equivalent | Imed Corp. |
FEI Numbers
This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.