Product code KCJ
- Device name
- Applicator, Ent
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5220
- Review panel
- EN
- 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 |
|---|---|---|---|
| K923679 | ENDOPATH TISSUE RETAINING COMPONENT | Ethicon Endo-Surgery, Inc. | 1992-09-09 |
| K921053 | LAPAROMED LIGATING LOOP | Laparomed Corp. | 1992-08-06 |
| K894369 | APDYNE PHENOL APPLICATOR KIT | Apdyne Medical Co. | 1989-10-12 |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Kells Medical, Inc. | 1983-09-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04054462901289 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462901296 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462901302 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462901326 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462901333 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462901340 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462903146 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462918133 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462901265 | evonos | evonos GmbH & Co. KG | 2026-08-18 |
| 04054462915132 | evonos | evonos GmbH & Co. KG | 2026-08-17 |
| 04054462916801 | evonos | evonos GmbH & Co. KG | 2026-08-14 |
| 04054462916825 | evonos | evonos GmbH & Co. KG | 2026-08-14 |
| 16973069980143 | APPLICATOR | Dalian Rongbang Medical Healthy Devices Co., Ltd. | 2022-09-07 |
| 10381780402800 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780402817 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780402763 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-09 |
| 10381780198178 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-23 |
| 10381780198192 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-23 |
| 10381780390497 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-23 |
| 10381780390503 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-23 |
| 10381780418825 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418832 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418856 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418863 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418887 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418894 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418924 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418931 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780198185 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-10-31 |
| 10381780166825 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |