Tonsil Snares
FDA 510(k) K822188 · Kelleher Corp.
510(k) numberK822188
Submission
- Device name
- Tonsil Snares
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 23, 1982
- Decision date
- August 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KBZ – Snare, Tonsil
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
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 Tonsil Snares cleared by the FDA?
Tonsil Snares (K822188) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 32 days after the submission was received.
What is the product code of K822188?
The FDA product code is KBZ – Snare, Tonsil, a Class I (low risk) device regulated under 21 CFR 874.4420.