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 devicesShowing 1-50 of 56
Frequently asked questions
How many devices does Surgikos, Inc. have in the registry?
The registry currently lists 56 devices for Surgikos, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgikos, Inc.'s devices?
Among its 50 most recently registered devices, Surgikos, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Surgikos, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Surgikos, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgikos, Inc. in the registry?
The most recently registered devices listed for Surgikos, Inc. include EDGE PROTECTOR, BARRIER, BARRIER PEDIATRIC/INCISE DRAPE 450, BARRIER GENERAL SURGERY PACK and BARRIER ANTIMICROBIAL INCISE DRAPE.