FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VALVOTOMY KNIFE
K Number: K843371
·
Decision Oct 25, 1984
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
20
Applicant Total
60
Review Days
58
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
- VALVOTOMY KNIFE
- K Number
- K843371
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Downs Surgical , Ltd.
- Date Received
- August 28, 1984
- Decision Date
- October 25, 1984
- Product Code
- EMF
- 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 |
|---|---|---|---|
| EMF | Knife, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMF), ordered by most recent decision date.
MOUNTABLE ENDOSCOPIC BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MOUNTABLE ENDOSCOPIC KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROSURGICAL KNIVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROSURGERY RAZOR BLADE HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROSURGICAL SCARIFIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VAN-TEC ENDOPYELOTOMY KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Downs Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Oct 31, 1990 | Substantially Equivalent |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Oct 31, 1990 | Substantially Equivalent |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Oct 31, 1990 | Substantially Equivalent |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Oct 31, 1990 | Substantially Equivalent |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Oct 22, 1990 | Substantially Equivalent |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Oct 22, 1990 | Substantially Equivalent |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Oct 22, 1990 | Substantially Equivalent |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Oct 22, 1990 | Substantially Equivalent |
| K900616 | SHEPPERD CUTTING FORCEPS | Oct 22, 1990 | Substantially Equivalent |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Oct 22, 1990 | Substantially Equivalent |