FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMP CAPD UNISPIKE AMINISTRATION SET
K Number: K822551
·
Decision Oct 13, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
30
Review Days
50
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
- AMP CAPD UNISPIKE AMINISTRATION SET
- K Number
- K822551
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Medical Products, Inc.
- Date Received
- August 24, 1982
- Decision Date
- October 13, 1982
- 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.
TUBING CLAMP CAT#1000-A
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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
FLOWCLAMP CAT.#1011 & 1012
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by American Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922290 | SINGLE-STEP PREGNANCY, HCG TEST | Jul 9, 1992 | Substantially Equivalent |
| K862221 | E-Z CLEAN | Sep 12, 1986 | Substantially Equivalent |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | Apr 17, 1986 | Substantially Equivalent |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | Jun 2, 1983 | Substantially Equivalent |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | Mar 17, 1983 | Substantially Equivalent |
| K822545 | CCPD CYCLER SET W/5 PRONGED CONNECTOR | Oct 13, 1982 | Substantially Equivalent |
| K822546 | SAFE LOCK SEALING CAPS | Oct 13, 1982 | Substantially Equivalent |
| K822543 | CAPD SAFE LOCK TRANSFER SET | Oct 13, 1982 | Substantially Equivalent |
| K822544 | SAFE LOCK SEALING CAP L | Oct 13, 1982 | Substantially Equivalent |
| K822548 | SAFE LOCK CATHETER S-3 | Oct 13, 1982 | Substantially Equivalent |