Surgikos, Inc.
Mchenry, IL, US
Surgikos, Inc. appears in FDA device records in Mchenry, IL. FDA records list 56 510(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
- 56
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 56FDA records hold 56 510(k) clearances for Surgikos, Inc. between 1976 and 1988. The busiest year on record is 1976, with 15. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 15 |
| 1977 | 5 |
| 1978 | 10 |
| 1979 | 14 |
| 1980 | 3 |
| 1981 | 2 |
| 1982 | 3 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K875107 | HEALTH CARE EYE PROTECTION | HOY | Substantially Equivalent | |
| K874653 | STERILE SURGICAL SCRUB BRUSH | GEC | Substantially Equivalent | |
| K861441 | NEUTRALON SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K852870 | BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | |
| K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION | FKQ | Substantially Equivalent | |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | KKX | Substantially Equivalent | |
| K820542 | SURGIKOS INCISE DRAPE | KKX | Substantially Equivalent | |
| K811871 | BACTERICIDAL INCISE DRAPE | KKX | Substantially Equivalent | |
| K810316 | SURGIKOS FACE MASK | FXX | Substantially Equivalent | |
| K801864 | BARRIER APERTURED DRAPE | KKX | Substantially Equivalent | |
| K801863 | BARRIER TOWEL DRAPE | KKX | Substantially Equivalent | |
| K800152 | SURGIKOS NEUTRALON BR. SURGEON'S GLOVE | KGO | Substantially Equivalent | |
| K791719 | BARRIER & FACE MASK WITH INNER FACING | KKX | Substantially Equivalent | |
| K791500 | BARRIER *450* TAPE STRIP | KKX | Substantially Equivalent | |
| K791486 | FABRIC 450* TOWEL DRAPE | KKX | Substantially Equivalent | |
| K791440 | BARRIER* X-RAY CASSETTE DRAPE | KKX | Substantially Equivalent | |
| K791439 | BARRIER* OVERHEAD TABLE DRAPE | KKX | Substantially Equivalent | |
| K791438 | BARRIER* C-ARM DRAPE | KKX | Substantially Equivalent | |
| K791032 | CARDIAC CATHETERIZATION SHEETS/PACKS | KKX | Substantially Equivalent | |
| K790804 | PURGE LINE UNIT | DTL | Substantially Equivalent | |
| K790725 | BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* | KKX | Substantially Equivalent | |
| K790431 | TREATED BARRIER INCISE DRAPE | KKX | Substantially Equivalent | |
| K790435 | INTERSEPT* BLOOD FILTER W/ TUBING BYPASS | DTM | Substantially Equivalent | |
| K790306 | EDGE PROTECTOR, BARRIER | KGW | Substantially Equivalent | |
| K790225 | LIMB SHEET WITH FABRIC 450 | KKX | Substantially Equivalent | |
| K790224 | PADIATRY PACK & SHEET WITH FABRIC 450 | KKX | Substantially Equivalent | |
| K781861 | FILTER, EXTRACORPOREAL BLOOD HOLDER | KRI | Substantially Equivalent | |
| K781707 | FILTER, ARTERIAL BLOOD W/TUBING BYPASS | DTM | Substantially Equivalent | |
| K780856 | BARRIER GYNECOLOGY PACK FABRIC 450 | KKX | Substantially Equivalent | |
| K780844 | BARRIER OBSTETRICAL PACK FABRIC 450 | KKX | Substantially Equivalent | |
| K780843 | BARRIER ABDOMINAL PACK FABRIC 450 | KKX | Substantially Equivalent | |
| K780842 | BARRIER BASIC PACK FABRIC 450 | KKX | Substantially Equivalent | |
| K780841 | BARRIER MEDIUM SHEET 450 | KKX | Substantially Equivalent | |
| K780840 | BARRIER LAPAROTOMY SHEET 450 | KKX | Substantially Equivalent | |
| K780839 | BARRIER PEDIATRIC/INCISE DRAPE 450 | KKX | Substantially Equivalent | |
| K780282 | BARRIER HIP PACK W/ FABRIC 450 | Substantially Equivalent | ||
| K772182 | SURGICAL GOWN, REINFORCED | FYA | Substantially Equivalent | |
| K770560 | BARRIER O.B. PACK IV | KKX | Substantially Equivalent | |
| K770250 | GOWN, SURGICAL, SURGINE | BZQ | Substantially Equivalent | |
| K761204 | BARRIER IMPERVIOUS BACK TABLE COVER | KKX | Substantially Equivalent | |
| K760896 | BARRIER ORTHOPAEDIC SPLIT SHEET | Substantially Equivalent | ||
| K760937 | BARRIER NEURO SHEET | KKX | Substantially Equivalent | |
| K760991 | SURGINE FACE MASK | FXX | Substantially Equivalent | |
| K760554 | APPAREL, BARRIER SCRUB | FYA | Substantially Equivalent | |
| K760933 | BARRIER UNIVERSAL SHEET | KKX | Substantially Equivalent | |
| K760903 | BARRIER FABRIC 450 SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K760902 | BARRIER UNDER BUTTOCKS DRAPE | Substantially Equivalent | ||
| K760890 | BARRIER IMPERVIOUS S-OCKINETTE | KKX | Substantially Equivalent | |
| K760865 | BARRIER FASHION BONNET | FXY | Substantially Equivalent | |
| K760864 | BARRIER FABRIC 450 SPECIALTY GOWN | FYA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- GECBrush, Scrub, Operating-Room
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- KKXDrape, Surgical, Antimicrobial
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- FYAGown, Surgical
- FXYHood, Surgical
- FXXMask, Surgical
- CAKMicrofilter, Blood Transfusion
- BZQMonitor, Breathing Frequency
- KGWRing (Wound Protector), Drape Retention, Internal
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KGOSurgeon'S Gloves
- FKQSystem, Dialysate Delivery, Central Multiple Patient
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Surgikos, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Surgikos, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain