Product Code: EMF
FDA class 1
21 CFR 878.4800
Knife, Surgical
General, Plastic Surgery
The Surgical Knife is a general-purpose scalpel or blade handle used across surgical disciplines, including general and plastic surgery, to make precise incisions through tissue during operative procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EMF, regulated under 21 CFR 878.4800 in the General, Plastic Surgery (SU) specialty.
510(k)s
21
FEI Numbers
227
Registration Numbers
227
Unique Applicants
16
Years Active
29
Basic Information
- Product Code
- EMF
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | Mar 13, 2008 | Substantially Equivalent | A.M. SURGICAL, INC. |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | Dec 30, 1998 | Substantially Equivalent | A.M. SURGICAL, INC. |
| K890217 | MICROSURGICAL KNIVES | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K890215 | MICROSURGICAL SCARIFIER | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Feb 29, 1988 | Substantially Equivalent | VAN-TEC, INC. |
| K863752 | VALTRAC (BAR) REMOVER DEVICE | Oct 24, 1986 | Substantially Equivalent | DAVIS & GECK, INC. |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Sep 30, 1986 | Substantially Equivalent | SURGIPATH MEDICAL INDUSTRIES, INC. |
| K861947 | SURGICAL KNIFE | Jun 06, 1986 | Substantially Equivalent | SHARPOINT, INC. |
| K854891 | KNIFE | May 02, 1986 | Substantially Equivalent | EURO-MED INTL. |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Jun 20, 1985 | Substantially Equivalent | ARTIBERIA |
| K843497 | SURGICAL KNIVES & PROBES | Oct 31, 1984 | Substantially Equivalent | EDER INSTRUMENT CO, INC. |
| K843371 | VALVOTOMY KNIFE | Oct 25, 1984 | Substantially Equivalent | DOWNS SURGICAL LTD. |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Jan 27, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Jan 27, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Oct 31, 1983 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K821769 | MICROKNIFE | Sep 14, 1982 | Substantially Equivalent | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES |
| K801585 | HESSBURG-BFRRON TREPHINE | Oct 03, 1980 | Substantially Equivalent | PRECISION INSTRUMENTS, INC. |
| K791286 | WECK MICROSURGICAL KNIFE | Jul 24, 1979 | Substantially Equivalent | VISTA MEDICAL PRODUCTS, INC. |
| K780991 | PARALLEL BLADE MARKER | Oct 03, 1978 | Substantially Equivalent | NESTOR ENGINEERING ASSOCIATES, INC. |
| K780989 | DEVIN-NESTOR SQUARE KNIFE | Oct 03, 1978 | Substantially Equivalent | NESTOR ENGINEERING ASSOCIATES, INC. |
FEI Numbers
This FDA classification entry is associated with 227 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 227 registration numbers. Click on an entry to view related FDA registrations.