Ear Snares
FDA 510(k) K822199 · Kelleher Corp.
510(k) numberK822199
Submission
- Device name
- Ear Snares
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 23, 1982
- Decision date
- August 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZD – Snare, Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K834168 | Fibrinogen Uptake Sys -Various ModelsJZD · Traditional | Canberra Industries, Inc. | 12/29/1983SE |
More from Canberra Industries, Inc.
| 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 Ear Snares cleared by the FDA?
Ear Snares (K822199) received a 510(k) decision of Substantially Equivalent on August 25, 1982, 33 days after the submission was received.
What is the product code of K822199?
The FDA product code is JZD – Snare, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.