Surgicot, Inc.
Mchenry, IL, US
Surgicot, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Surgicot, Inc. between 1977 and 1997. The busiest year on record is 1977, with 7. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 7 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1986 | 4 |
| 1994 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | FRG | Substantially Equivalent | |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | FLG | Substantially Equivalent | |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | FRC | Substantially Equivalent | |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | FRC | Substantially Equivalent | |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | FRC | Substantially Equivalent | |
| K854902 | SURGICOT STEAM TEST PACK | FRC | Substantially Equivalent | |
| K840541 | NEURO SPONGE | GDY | Substantially Equivalent | |
| K840471 | EYE SPEAR | HOZ | Substantially Equivalent | |
| K840470 | SURGISCRIBE MARKING PEN | FZZ | Substantially Equivalent | |
| K830739 | PRO-GUARD | FRG | Substantially Equivalent | |
| K820302 | SURGIPEEL SELF-SEAL PACKAGING SYSTEM | FRG | Substantially Equivalent | |
| K800029 | SURGICOT 2 INDICATOR SYSTEM | FRC | Substantially Equivalent | |
| K771846 | SUOGIPEEL PACKAGING SYSTEM | FRG | Substantially Equivalent | |
| K771032 | POUCHES, PEEL OPEN, BREATHABLE | FRG | Substantially Equivalent | |
| K770593 | CORRUGATED TUBING #770 & 771 | BZO | Substantially Equivalent | |
| K770587 | VENTILATOR ADAPTOR, #751 | BZA | Substantially Equivalent | |
| K770586 | UNIVERSAL MOUTHPIECE, #750 | BYP | Substantially Equivalent | |
| K770585 | AEROSOL T ADAPTER, #752 | BZA | Substantially Equivalent | |
| K761254 | BAND-AGE ICE-BANDAGE | ILO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FLGCleaner, Ultrasonic, Medical Instrument
- BZAConnector, Airway (Extension)
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FRCIndicator, Biological Sterilization Process
- FZZMarker, Skin
- BYPMouthpiece, Breathing
- ILOPack, Hot Or Cold, Water Circulating
- BZOSet, Tubing And Support, Ventilator (W Harness)
- HOZSponge, Ophthalmic
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain