FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCMT UMBILICAL CLAMP
K Number: K871075
·
Decision Mar 23, 1987
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
8
Review Days
5
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
- SCMT UMBILICAL CLAMP
- K Number
- K871075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Salt Creek Medical Technologies
- Date Received
- March 18, 1987
- Decision Date
- March 23, 1987
- Product Code
- HFW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFW), ordered by most recent decision date.
JOEY CLAMP OPENING TOOL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KAEN YIH UMBILICAL CORD CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BUSSE UMBILICAL CORD CLAMP CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOALA CLAMP, KOALA CLAMP AND CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Salt Creek Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K864683 | NEONATAL FEEDING KIT | Apr 17, 1987 | Substantially Equivalent |
| K871042 | URINE METER, 250CC | Mar 25, 1987 | Substantially Equivalent |
| K871087 | S.C.M.T. PERFORATOR | Mar 23, 1987 | Substantially Equivalent |
| K864296 | S.C.T. MULTI PORT, INJECTION SITE | Mar 2, 1987 | Substantially Equivalent |
| K864682 | SALT CREEK P.I. TRAY | Jan 6, 1987 | Substantially Equivalent |
| K864692 | EXTENSION SETS | Dec 18, 1986 | Substantially Equivalent |
| K864693 | I.V. START KITS | Dec 16, 1986 | Substantially Equivalent |