FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICLEAN ENZYMATIC INSTRUMENT CLEANER
K Number: K931270
·
Decision Apr 13, 1994
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
18
Applicant Total
19
Review Days
401
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Basic Information
- Device Name
- SURGICLEAN ENZYMATIC INSTRUMENT CLEANER
- K Number
- K931270
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgicot, Inc.
- Date Received
- March 8, 1993
- Decision Date
- April 13, 1994
- Product Code
- FLG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | FDA class 1 | General Hospital |
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INSTRU KLENZ
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Other Clearances by Surgicot, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | Mar 11, 1997 | 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 |
| K840470 | SURGISCRIBE MARKING PEN | Mar 12, 1984 | Substantially Equivalent |
| K830739 | PRO-GUARD | Mar 29, 1983 | Substantially Equivalent |
| K820302 | SURGIPEEL SELF-SEAL PACKAGING SYSTEM | Feb 24, 1982 | Substantially Equivalent |