FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMBINATION NITE DRAINAGE UNIT
K Number: K872294
·
Decision Dec 29, 1987
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
101
Applicant Total
2
Review Days
196
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
- COMBINATION NITE DRAINAGE UNIT
- K Number
- K872294
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Arnold Technologies
- Date Received
- June 16, 1987
- Decision Date
- December 29, 1987
- Product Code
- EXB
- 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 |
|---|---|---|---|
| EXB | Collector, Ostomy | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXB), ordered by most recent decision date.
Heylo System
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SmartBag (SmartPouch)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
OSTOM-I ALERT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LAKE OSTOMY CARE SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ODOR-END EMERGENCY CLEAN UP POWDER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Arnold Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K870136 | PERSONAL PUNCH | Apr 1, 1987 | Substantially Equivalent |