FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGISCRIBE MARKING PEN
K Number: K840470
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
19
Review Days
38
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Basic Information
- Device Name
- SURGISCRIBE MARKING PEN
- K Number
- K840470
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgicot, Inc.
- Date Received
- February 3, 1984
- Decision Date
- March 12, 1984
- Product Code
- FZZ
- 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 |
|---|---|---|---|
| FZZ | Marker, Skin | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZZ), ordered by most recent decision date.
SURGICHIP TAG SURGICAL MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BLOOM TRANSPARENT STENCIL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROCKET SURGICAL SKIN MARKING PEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUALTEX SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Surgicot, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | Mar 11, 1997 | Substantially Equivalent |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Apr 13, 1994 | Substantially Equivalent |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | Dec 17, 1986 | Substantially Equivalent |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | Jul 17, 1986 | Substantially Equivalent |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | May 27, 1986 | Substantially Equivalent |
| K854902 | SURGICOT STEAM TEST PACK | May 20, 1986 | Substantially Equivalent |
| K840541 | NEURO SPONGE | Apr 23, 1984 | Substantially Equivalent |
| K840471 | EYE SPEAR | Mar 16, 1984 | Substantially Equivalent |
| K830739 | PRO-GUARD | Mar 29, 1983 | Substantially Equivalent |
| K820302 | SURGIPEEL SELF-SEAL PACKAGING SYSTEM | Feb 24, 1982 | Substantially Equivalent |