Product code KBH
- Device name
- Adenotome
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4420
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822262 | ADENOTOMES | Kelleher Corp. | 1982-08-25 |
Related GUDID Devices#
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|---|---|---|---|
| 00757770430055 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-07-29 |
| 00757770429974 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-07-29 |
| 00757770424443 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-07-29 |
| 00757770420322 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-07-29 |
| 00190776381943 | Millennium | Avalign Technologies, Inc. | 2024-04-30 |
| G586E8221210 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| 00887482192825 | Symmetry Surgical | ASPEN SURGICAL PRODUCTS, INC. | 2022-12-08 |
| 00887482192832 | Symmetry | ASPEN SURGICAL PRODUCTS, INC. | 2022-12-08 |
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| 10885403115004 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
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| 10885403114984 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
| 10885403114977 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
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| 10885403114939 | V. Mueller | STERIS CORPORATION | 2018-09-14 |
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