Operative Ear Currettes & Related Item
FDA 510(k) K822006 · Kelleher Corp.
510(k) numberK822006
Submission
- Device name
- Operative Ear Currettes & Related Item
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 8, 1982
- Decision date
- August 12, 1982
- 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 |
| K852039 | Flex-Loop Flexible Ear CoretteJYG · Traditional | Bionix Corp. | 06/11/1985SE |
| 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 |
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
Questions and answers
When was Operative Ear Currettes & Related Item cleared by the FDA?
Operative Ear Currettes & Related Item (K822006) received a 510(k) decision of Substantially Equivalent on August 12, 1982, 35 days after the submission was received.
What is the product code of K822006?
The FDA product code is JYG – Curette, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.