Product code KAL
- Device name
- Retractor, Ent
- 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 |
|---|---|---|---|
| K870758 | SMALL MASTOID RETRACTOR | Treace Medical, Inc. | 1987-03-04 |
| K833604 | ADJUSTABLE FORK RETRACTOR | Microtek Medical, Inc. | 1984-01-03 |
| K772381 | RING HANDLE & RETRACTORS | Edward Weck, Inc. | 1978-01-17 |
| K772392 | ALLPORT MASTOID RETRACTORS | Edward Weck, Inc. | 1978-01-17 |
| K760851 | CONVERSE ALTAR RETRACTOR | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04054462156498 | evonos | evonos GmbH & Co. KG | 2026-08-26 |
| 04054462156504 | evonos | evonos GmbH & Co. KG | 2026-08-26 |
| 04054462913039 | evonos | evonos GmbH & Co. KG | 2026-08-26 |
| 04054462913213 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913275 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913251 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913237 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913169 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913145 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913138 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913121 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913107 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913091 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913077 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913114 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913060 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 00190776417710 | Millennium | Avalign Technologies, Inc. | 2026-08-19 |
| 00190776417253 | Millennium | Avalign Technologies, Inc. | 2026-08-19 |
| 04054462913152 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462916139 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915934 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915927 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915897 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915880 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915873 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915859 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915842 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915835 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462915828 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 00190660141578 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |