FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIACHAR MODIFIED ESOPHAGEAL STENT
K Number: K904821
·
Decision Jan 14, 1991
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
19
Review Days
82
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Basic Information
- Device Name
- ELIACHAR MODIFIED ESOPHAGEAL STENT
- K Number
- K904821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Hood Laboratories
- Date Received
- October 24, 1990
- Decision Date
- January 14, 1991
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Hood Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K921452 | ACOUSTIC RHINOMETER | Jul 8, 1993 | Substantially Equivalent |
| K920994 | HOOD NASAL SEPTAL BUTTON | May 15, 1992 | Substantially Equivalent |
| K905703 | KRUPIN EYE VALVE WITH DISK | Mar 15, 1991 | Substantially Equivalent |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | Mar 16, 1990 | Substantially Equivalent |
| K897059 | HOOD SPEAKING VALVE | Mar 12, 1990 | Substantially Equivalent |
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | Aug 7, 1989 | Substantially Equivalent |
| K884810 | SILICONE LARYNGEAL STENT | May 10, 1989 | Substantially Equivalent |
| K890599 | HOOD NASAL SPLINT | Mar 17, 1989 | Substantially Equivalent |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | Jan 24, 1989 | Substantially Equivalent |
| K882430 | HOOD TRACHEAL STOMA BUTTON | Jun 28, 1988 | Substantially Equivalent |