FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICOT 2 INDICATOR SYSTEM
K Number: K800029
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
19
Review Days
65
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Basic Information
- Device Name
- SURGICOT 2 INDICATOR SYSTEM
- K Number
- K800029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Surgicot, Inc.
- Date Received
- January 7, 1980
- Decision Date
- March 12, 1980
- Product Code
- FRC
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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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 |
| 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 |
| K840470 | SURGISCRIBE MARKING PEN | Mar 12, 1984 | Substantially Equivalent |
| K830739 | PRO-GUARD | Mar 29, 1983 | Substantially Equivalent |