FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERECAID(R) SYSTEM PLUS
K Number: K912736
·
Decision Aug 12, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
4
Review Days
52
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
- ERECAID(R) SYSTEM PLUS
- K Number
- K912736
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osbon Medical Systems, Ltd.
- Date Received
- June 21, 1991
- Decision Date
- August 12, 1991
- Product Code
- LKY
- 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKY), ordered by most recent decision date.
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VACURECT VACUUM CONSTRICTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANMA VACUUM PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO NANMA VACUUM PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology