Product code FMA
- Device name
- Depressor, Tongue, Non-Surgical
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6230
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992995 | AROMATIC AND FLAVORED TONGUE DEPRESSOR | Aga Plastic Ind. Com. Ltda. | 1999-12-09 |
| K842461 | TONGUE DEPRESSOR | The Torrent Corp. | 1984-11-30 |
| K830705 | MINI LANCET-BLOOD LANCET | Pharmaquest Corp. | 1983-04-08 |
| K821177 | BITE STICK | Abco Dealers, Inc. | 1982-05-21 |
| K770120 | MOUTH WASH TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M2207250003 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2025-09-11 |
| M220769000 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2025-09-11 |
| M220770001 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2025-09-11 |
| 10080196158744 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-01-17 |
| 10080196158768 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-01-17 |
| 00609576370809 | Puritan | Puritan Medical Products | 2022-12-08 |
| 00609576370038 | Puritan | Puritan Medical Products | 2022-12-08 |
| 00609576370021 | Puritan | Puritan Medical Products | 2022-12-08 |
| 00609576370014 | Puritan | Puritan Medical Products | 2022-12-08 |
| 16973069980013 | Depressors | Dalian Rongbang Medical Healthy Devices Co., Ltd. | 2022-09-07 |
| 10732224003211 | Tongue Depressors | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 20885380021081 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-09-13 |
| ESAM3701011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3700001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3701021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 10686864048784 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-16 |
| 10686864049170 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-16 |
| 10686864048869 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-16 |
| 10686864048791 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-16 |
| 10686864048654 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-16 |
| 10686864048647 | AMD-RITMED SOLON | AMD Medicom Inc | 2019-01-16 |
| 10686864048388 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |
| 10686864048364 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |
| 10686864048340 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |
| 00612479135727 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-10-05 |
| 00612479137059 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-10-05 |
| 00612479137073 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-10-05 |
| 00612479137097 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-10-05 |
| 10381780216186 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780216179 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |