Product code JYG
- Device name
- Curette, Ear
- 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 |
|---|---|---|---|
| K932609 | EAR CURETTE | Ear Tech, Inc. | 1993-07-21 |
| K852039 | FLEX-LOOP FLEXIBLE EAR CORETTE | Bionix Corp. | 1985-06-11 |
| K841354 | CURETTE | Treace Medical, Inc. | 1984-07-06 |
| K841001 | EAR CURETTE, VARIOUS | Premier Dental Products Co. | 1984-05-29 |
| K823916 | WAX CURETTE TIP | Treace Medical, Inc. | 1983-01-21 |
| K822273 | ENT CURRETTES | Kelleher Corp. | 1982-08-30 |
| K822006 | OPERATIVE EAR CURRETTES & RELATED ITEM | Kelleher Corp. | 1982-08-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190776434304 | Millennium | Avalign Technologies, Inc. | 2026-10-06 |
| 00724995273965 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995273958 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271800 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271657 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271640 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271633 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271626 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271275 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271268 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271251 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995271244 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00859911004726 | Lighted Placement Tool | Bionix, LLC | 2022-08-08 |
| 00859911004580 | Lighted InfantScoop® | Bionix, LLC | 2021-12-10 |
| 00859911004603 | Lighted CeraPik™ | Bionix, LLC | 2021-12-10 |
| 00859911004597 | Lighted VersaLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004573 | Lighted CeraSpoon® | Bionix, LLC | 2021-12-10 |
| 00859911004566 | Lighted Ear Curette™ Variety Pack | Bionix, LLC | 2021-12-10 |
| 00859911004559 | Lighted FlexLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004542 | Lighted WaveCurette™ | Bionix, LLC | 2021-12-10 |
| 00859911004535 | Lighted MicroLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004528 | Lighted AngleLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004481 | White FlexLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004474 | Yellow CeraSpoon® | Bionix, LLC | 2021-12-10 |
| 00859911004467 | Blue InfantScoop® | Bionix, LLC | 2021-12-10 |
| 00859911004450 | Purple VersaLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004443 | Red AngleLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004436 | Orange ControLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004429 | Green MicroLoop® | Bionix, LLC | 2021-12-10 |
| 00859911004498 | Safe Ear Curette™ Variety Kit | Bionix, LLC | 2021-12-10 |