FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
K Number: K000154
·
Decision Mar 29, 2000
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
3
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
- K Number
- K000154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- E. Benson Hood Lab, Inc.
- Date Received
- January 19, 2000
- Decision Date
- March 29, 2000
- Product Code
- FWN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FWN | Prosthesis, Larynx (Stents And Keels) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWN), ordered by most recent decision date.
RUTTER SUPRA STOMAL STENTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LORENZ STENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SILICONE LARYNGEAL STENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LARYNGEAL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat