Surgikos, Inc.
United StatesFDA applicant, unverified
- Devices
- 56
What Surgikos, Inc. makes
Surgikos, Inc. manufactures sterile surgical barrier products, including incise drapes (general surgery and pediatric), impervious gowns, surgical gloves, back table covers, and occlusive sockinette. The company also produces surgical scrub brushes, purge line units, and combined barrier masks with inner facings. These items are designed to prevent contamination during surgical procedures.
The company’s products are regulated under FDA’s Class I and Class II device classifications and are listed via the 510(k) pathway. These items are intended for use in sterile surgical environments and are subject to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 56 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
Treated Barrier Incise Drape Ref K790431
Regimes: 510(k) Registry: 510(k)Barrier Abdominal Pack Fabric 450 Ref K780843
Regimes: 510(k) Registry: 510(k)Health Care Eye Protection Ref K875107
Regimes: 510(k) Registry: 510(k)Padiatry Pack & Sheet With Fabric 450 Ref K790224
Regimes: 510(k) Registry: 510(k)Surgine Face Mask Ref K760991
Regimes: 510(k) Registry: 510(k)Barrier Under Buttocks Drape Ref K760902
Regimes: 510(k) Registry: 510(k)
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