Emergency Tracheostomy Instrument Set
FDA 510(k) K822618 · Kelleher Corp.
510(k) numberK822618
Submission
- Device name
- Emergency Tracheostomy Instrument Set
- Applicant
- Kelleher Corp.
Richmond, VA, US - Received
- September 2, 1982
- Decision date
- January 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJW – Tracheotome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LJW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933570 | Resolution(Tm) Hip StemLJW · Traditional | Wrightmedicaltechnologyinc | 03/07/1994SN |
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| 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 |
| K822185 | Laryngeal SyringeFMF · Traditional | 10/18/1982SE |
Questions and answers
When was Emergency Tracheostomy Instrument Set cleared by the FDA?
Emergency Tracheostomy Instrument Set (K822618) received a 510(k) decision of Substantially Equivalent on January 28, 1983, 148 days after the submission was received.
What is the product code of K822618?
The FDA product code is LJW – Tracheotome, a Class I (low risk) device regulated under 21 CFR 874.4420.