FMA · Depressor, Tongue, Non-Surgical
General Hospital · 21 CFR 880.6230 · Class 1
Overview
| Product Code | FMA |
|---|---|
| Device Name | Depressor, Tongue, Non-Surgical |
| Regulation | 21 CFR 880.6230 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
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 § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992995 | AROMATIC AND FLAVORED TONGUE DEPRESSOR | Aga Plastic Ind. Com. Ltda. | Dec 9, 1999 | SESE |
| K842461 | TONGUE DEPRESSOR | The Torrent Corp. | Nov 30, 1984 | SESE |
| K830705 | MINI LANCET-BLOOD LANCET | Pharmaquest Corp. | Apr 8, 1983 | SESE |
| K821177 | BITE STICK | Abco Dealers, Inc. | May 21, 1982 | SESE |
| K770120 | MOUTH WASH TRAY | Pharmaseal Div., Baxter Healthcare Corp. | Jan 28, 1977 | SESE |
Top Applicants
- Abco Dealers, Inc. — 1 clearance
- Aga Plastic Ind. Com. Ltda. — 1 clearance
- Pharmaquest Corp. — 1 clearance
- Pharmaseal Div., Baxter Healthcare Corp. — 1 clearance
- The Torrent Corp. — 1 clearance
