Depressor, Tongue, Non-Surgical
The Non-Surgical Tongue Depressor is a flat wooden or plastic stick used during physical examinations to hold down the tongue so that the throat, tonsils, and mouth can be visually inspected. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMA, regulated under 21 CFR 880.6230 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FMA
- Device Class
- FDA class 1
- Regulation Number
- 880.6230
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992995 | AROMATIC AND FLAVORED TONGUE DEPRESSOR | Dec 09, 1999 | Substantially Equivalent | Aga Plastic Ind. Com. Ltda. |
| K842461 | TONGUE DEPRESSOR | Nov 30, 1984 | Substantially Equivalent | The Torrent Corp. |
| K830705 | MINI LANCET-BLOOD LANCET | Apr 08, 1983 | Substantially Equivalent | Pharmaquest Corp. |
| K821177 | BITE STICK | May 21, 1982 | Substantially Equivalent | Abco Dealers, Inc. |
| K770120 | MOUTH WASH TRAY | Jan 28, 1977 | Substantially Equivalent | Pharmaseal Div., Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 219 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 219 registration numbers. Click on an entry to view related FDA registrations.