FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBING CLAMP CAT#1000-A
K Number: K854512
·
Decision Dec 2, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
2
Review Days
20
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
- TUBING CLAMP CAT#1000-A
- K Number
- K854512
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Rao Medical Devices, Inc.
- Date Received
- November 12, 1985
- Decision Date
- December 2, 1985
- Product Code
- FKK
- 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 |
|---|---|---|---|
| FKK | Clamp, Line | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKK), ordered by most recent decision date.
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CLAMP, TUBING, LINE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
EMPTY DIALYSATE CONTAINER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
AMP CAPD UNISPIKE AMINISTRATION SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
FLOWCLAMP CAT.#1011 & 1012
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Rao Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854965 | IN LINE VALVE CATALOG NO. 2000A | Feb 21, 1986 | Substantially Equivalent |