FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEEDLES, DESIGN CHANGE, IV CATHETERS
K Number: K780896
·
Decision Aug 23, 1978
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
7
Applicant Total
26
Review Days
85
Basic Information
- Device Name
- NEEDLES, DESIGN CHANGE, IV CATHETERS
- K Number
- K780896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Jelco Laboratories
- Date Received
- May 30, 1978
- Decision Date
- August 23, 1978
- Product Code
- GCB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCB | Needle, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCB), ordered by most recent decision date.
Valved Safety Centesis Catheter
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PARACENTESIS CATHETER DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ADAIR/VERESS NEEDLE INTRODUCER SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TURKEL PNEUMOTHORAX KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ADAIR/VERESS NEEDLE INTRODUCER SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Jelco Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | Oct 2, 1979 | Substantially Equivalent |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Sep 12, 1979 | Substantially Equivalent |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | Jun 27, 1979 | Substantially Equivalent |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | Jun 11, 1979 | Substantially Equivalent |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | Apr 30, 1979 | Substantially Equivalent |
| K790186 | PROTECTIVSTABILIZER | Feb 26, 1979 | Substantially Equivalent |
| K790079 | NEEDLE, BLOOD COLLECTING | Feb 1, 1979 | Substantially Equivalent |
| K790107 | CATHETER TUBING MODIFICATION | Feb 1, 1979 | Substantially Equivalent |
| K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING | Dec 11, 1978 | Substantially Equivalent |
| K780519 | FILTER TUBE | May 9, 1978 | Substantially Equivalent |