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 |
|---|---|---|---|
| 05060259070426 | Sigma Swab | MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | 2023-10-05 |
| 16973069980143 | APPLICATOR | Dalian Rongbang Medical Healthy Devices Co., Ltd. | 2022-09-07 |
| 00385640070126 | Apdyne | Summit Medical, Inc. | 2022-06-16 |
| 00616784432328 | Wood Applicator | Dynarex Corporation | 2021-09-01 |
| CRBFV2 | CLEARinse Nasal Aspirator | PENO LLC | 2020-06-10 |
| CRBFV1 | CLEARINSE | PENO LLC | 2019-08-01 |
| 00612479105720 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-10-05 |
| 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 |
| 10381780418863 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418825 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418832 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418931 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418924 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418894 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418887 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-12-21 |
| 10381780418856 | 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 |
| 00744229440758 | Montesol | PARI RESPIRATORY EQUIPMENT, INC. | 2016-10-05 |
| 00878799002860 | SURGISTAR | SURGISTAR, INC. | 2016-08-02 |
| 00878799002877 | SURGISTAR | SURGISTAR, INC. | 2016-08-02 |
| 00810988020545 | 5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER SET | JET MEDICAL, INC. | 2015-08-25 |
| 00810988020798 | 5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER ONLY | JET MEDICAL, INC. | 2015-08-25 |
| 00810988020811 | ".018""(0.46MM) X 35CM ALLEVIO GUIDEWIRE" | JET MEDICAL, INC. | 2015-07-20 |