FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NAJA Gastrointestinal Catheter
K Number: K223890
·
Decision Jun 16, 2023
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
1
Review Days
171
Basic Information
- Device Name
- NAJA Gastrointestinal Catheter
- K Number
- K223890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chess Medical Inc.
- Date Received
- December 27, 2022
- Decision Date
- June 16, 2023
- 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.
DUAL FLEX NON-LATEX
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