Flex-Loop Flexible Ear Corette
FDA 510(k) K852039 · Bionix Corp.
510(k) numberK852039
Submission
- Device name
- Flex-Loop Flexible Ear Corette
- Applicant
- Bionix Corp.
Holland, OH, US - Received
- May 9, 1985
- Decision date
- June 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JYG – Curette, Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932609 | Ear CuretteJYG · Traditional | Ear Tech, Inc. | 07/21/1993SE |
| K841354 | CuretteJYG · Traditional | Treace Medical, Inc. | 07/06/1984SE |
| K841001 | Ear Curette, VariousJYG · Traditional | Premier Dental Products Co. | 05/29/1984SE |
| K823916 | Wax Curette TipJYG · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K822273 | ENT CurrettesJYG · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822006 | Operative Ear Currettes & Related ItemJYG · Traditional | Kelleher Corp. | 08/12/1982SE |
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K860606 | Radiacare Intraoperative Radiotherapy SystemLHN · Traditional | 03/20/1986SE |
Questions and answers
When was Flex-Loop Flexible Ear Corette cleared by the FDA?
Flex-Loop Flexible Ear Corette (K852039) received a 510(k) decision of Substantially Equivalent on June 11, 1985, 33 days after the submission was received.
What is the product code of K852039?
The FDA product code is JYG – Curette, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.