FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUAL FLEX NON-LATEX
K Number: K905026
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
3
Review Days
406
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
- DUAL FLEX NON-LATEX
- K Number
- K905026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mmi, Inc.
- Date Received
- November 7, 1990
- Decision Date
- December 18, 1991
- Product Code
- FGD
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FGD | Catheter, Retention, Barium Enema With Bag | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGD), ordered by most recent decision date.
NAJA Gastrointestinal Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGLINTE ENTEROCLYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology