FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UMBILICAL CORD CLAMP
K Number: K880753
·
Decision Apr 27, 1988
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
41
Review Days
62
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
- UMBILICAL CORD CLAMP
- K Number
- K880753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- February 25, 1988
- Decision Date
- April 27, 1988
- 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 I M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | Dec 30, 1992 | Substantially Equivalent |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown |
| K881363 | SYRINGE PREFILLED WITH WATER | Jun 23, 1988 | Substantially Equivalent |
| K872741 | NUTRIPUMP | Oct 20, 1987 | Substantially Equivalent |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | May 8, 1987 | Substantially Equivalent |
| K863785 | MAKLER CATHETER | Dec 11, 1986 | Substantially Equivalent |
| K854155 | STERILE SALINE SOLUTION | Dec 10, 1985 | Substantially Equivalent |
| K853287 | HUBOUT | Oct 17, 1985 | Substantially Equivalent |
| K853288 | FEEDING UNITS & TUBES | Oct 4, 1985 | Substantially Equivalent |
| K853286 | STAPLE REMOVER | Aug 21, 1985 | Substantially Equivalent |