Company ยท US
Surgikos, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1988. Name variants (Inc, Corp, punctuation) are merged.
56510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 30 |
| FYA | Gown, Surgical | 5 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 |
| FXX | Mask, Surgical | 2 |
| FXY | Hood, Surgical | 2 |
| KGO | Surgeon'S Gloves | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CAK | Microfilter, Blood Transfusion | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| FYF | Cap, Surgical | 1 |
| GEC | Brush, Scrub, Operating-Room | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 1988 | K875107 | HEALTH CARE EYE PROTECTION Surgikos, Inc. | HOY |
| Dec 30, 1987 | K874653 | STERILE SURGICAL SCRUB BRUSH Surgikos, Inc. | GEC |
| May 30, 1986 | K861441 | NEUTRALON SURGICAL GLOVES Surgikos, Inc. | KGO |
| Jul 23, 1985 | K852870 | BARRIER SURGICAL GOWN Surgikos, Inc. | FYA |
| Sep 30, 1982 | K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION Surgikos, Inc. | FKQ |
| Jul 22, 1982 | K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE Surgikos, Inc. | KKX |
| Jun 2, 1982 | K820542 | SURGIKOS INCISE DRAPE Surgikos, Inc. | KKX |
| Aug 20, 1981 | K811871 | BACTERICIDAL INCISE DRAPE Surgikos, Inc. | KKX |
| Feb 23, 1981 | K810316 | SURGIKOS FACE MASK Surgikos, Inc. | FXX |
| Aug 20, 1980 | K801864 | BARRIER APERTURED DRAPE Surgikos, Inc. | KKX |
| Aug 20, 1980 | K801863 | BARRIER TOWEL DRAPE Surgikos, Inc. | KKX |
| Feb 19, 1980 | K800152 | SURGIKOS NEUTRALON BR. SURGEON'S GLOVE Surgikos, Inc. | KGO |
| Oct 4, 1979 | K791719 | BARRIER & FACE MASK WITH INNER FACING Surgikos, Inc. | KKX |
| Aug 28, 1979 | K791500 | BARRIER *450* TAPE STRIP Surgikos, Inc. | KKX |
| Aug 28, 1979 | K791486 | FABRIC 450* TOWEL DRAPE Surgikos, Inc. | KKX |
| Aug 28, 1979 | K791440 | BARRIER* X-RAY CASSETTE DRAPE Surgikos, Inc. | KKX |
| Aug 28, 1979 | K791439 | BARRIER* OVERHEAD TABLE DRAPE Surgikos, Inc. | KKX |
| Aug 28, 1979 | K791438 | BARRIER* C-ARM DRAPE Surgikos, Inc. | KKX |
| Jun 15, 1979 | K791032 | CARDIAC CATHETERIZATION SHEETS/PACKS Surgikos, Inc. | KKX |
| May 25, 1979 | K790804 | PURGE LINE UNIT Surgikos, Inc. | DTL |
| May 11, 1979 | K790725 | BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* Surgikos, Inc. | KKX |
| May 4, 1979 | K790431 | TREATED BARRIER INCISE DRAPE Surgikos, Inc. | KKX |
| Mar 27, 1979 | K790435 | INTERSEPT* BLOOD FILTER W/ TUBING BYPASS Surgikos, Inc. | DTM |
| Feb 22, 1979 | K790306 | EDGE PROTECTOR, BARRIER Surgikos, Inc. | KGW |
| Feb 21, 1979 | K790225 | LIMB SHEET WITH FABRIC 450 Surgikos, Inc. | KKX |
| Feb 16, 1979 | K790224 | PADIATRY PACK & SHEET WITH FABRIC 450 Surgikos, Inc. | KKX |
| Nov 15, 1978 | K781861 | FILTER, EXTRACORPOREAL BLOOD HOLDER Surgikos, Inc. | KRI |
| Oct 26, 1978 | K781707 | FILTER, ARTERIAL BLOOD W/TUBING BYPASS Surgikos, Inc. | DTM |
| Aug 14, 1978 | K780856 | BARRIER GYNECOLOGY PACK FABRIC 450 Surgikos, Inc. | KKX |
| Aug 14, 1978 | K780844 | BARRIER OBSTETRICAL PACK FABRIC 450 Surgikos, Inc. | KKX |
| Aug 14, 1978 | K780843 | BARRIER ABDOMINAL PACK FABRIC 450 Surgikos, Inc. | KKX |
| Aug 14, 1978 | K780842 | BARRIER BASIC PACK FABRIC 450 Surgikos, Inc. | KKX |
| Aug 14, 1978 | K780841 | BARRIER MEDIUM SHEET 450 Surgikos, Inc. | KKX |
| Aug 14, 1978 | K780840 | BARRIER LAPAROTOMY SHEET 450 Surgikos, Inc. | KKX |
| Aug 14, 1978 | K780839 | BARRIER PEDIATRIC/INCISE DRAPE 450 Surgikos, Inc. | KKX |
| Feb 28, 1978 | K780282 | BARRIER HIP PACK W/ FABRIC 450 Surgikos, Inc. | |
| Dec 8, 1977 | K772182 | SURGICAL GOWN, REINFORCED Surgikos, Inc. | FYA |
| Apr 5, 1977 | K770560 | BARRIER O.B. PACK IV Surgikos, Inc. | KKX |
| Mar 7, 1977 | K770250 | GOWN, SURGICAL, SURGINE Surgikos, Inc. | BZQ |
| Jan 12, 1977 | K761204 | BARRIER IMPERVIOUS BACK TABLE COVER Surgikos, Inc. | KKX |
| Jan 5, 1977 | K760896 | BARRIER ORTHOPAEDIC SPLIT SHEET Surgikos, Inc. | |
| Dec 21, 1976 | K760937 | BARRIER NEURO SHEET Surgikos, Inc. | KKX |
| Nov 16, 1976 | K760991 | SURGINE FACE MASK Surgikos, Inc. | FXX |
| Nov 12, 1976 | K760554 | APPAREL, BARRIER SCRUB Surgikos, Inc. | FYA |
| Nov 11, 1976 | K760933 | BARRIER UNIVERSAL SHEET Surgikos, Inc. | KKX |
| Nov 11, 1976 | K760903 | BARRIER FABRIC 450 SURGICAL GOWNS Surgikos, Inc. | FYA |
| Nov 11, 1976 | K760902 | BARRIER UNDER BUTTOCKS DRAPE Surgikos, Inc. | |
| Nov 11, 1976 | K760890 | BARRIER IMPERVIOUS S-OCKINETTE Surgikos, Inc. | KKX |
| Nov 3, 1976 | K760865 | BARRIER FASHION BONNET Surgikos, Inc. | FXY |
| Nov 3, 1976 | K760864 | BARRIER FABRIC 450 SPECIALTY GOWN Surgikos, Inc. | FYA |
Newest 50 of 56.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||