FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LARYNGEAL STENT
K Number: K841347
·
Decision May 2, 1984
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
6
Review Days
30
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Basic Information
- Device Name
- LARYNGEAL STENT
- K Number
- K841347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- E. Benson Hood Laboratories, Inc.
- Date Received
- April 2, 1984
- Decision Date
- May 2, 1984
- 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
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
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
Other Clearances by E. Benson Hood Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983878 | CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE | Jan 29, 1999 | Substantially Equivalent |
| K841350 | SALIVARY BYPASS TUBE | Jul 26, 1984 | Substantially Equivalent |
| K841349 | ESOPHAGEAL TUBE | Jul 23, 1984 | Substantially Equivalent |
| K841266 | MONTGOMERY TRACHEAL T-TUBE | Jun 14, 1984 | Substantially Equivalent |
| K841348 | UMBRELLA KEEL | May 2, 1984 | Substantially Equivalent |