Igenics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Igenics, Inc. makes
Igenics, Inc. manufactures synthetic sponges, including general-use sterile and non-sterile varieties, as well as drain/slit sponges in both sterile and non-sterile forms. These products are designed for surgical and medical applications to absorb fluids and maintain sterile environments during procedures.
The company’s portfolio is classified under FDA Device Class II (U) and is listed via 510(k) clearance in the United States. The products are regulated under the FDA’s medical device regulations, ensuring compliance with safety and performance standards for surgical and medical use.
Catalogue
Synthetic Sponge Ref K955165
Regimes: 510(k) Registry: 510(k)General Use Synthetic Sponge (Sterile) Ref K955527
Regimes: 510(k) Registry: 510(k)Drain/Slit Sponge (Non-Sterile And Sterile) Ref K963134
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Igenics, Inc. have in the registry?
The registry currently lists 3 devices for Igenics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Igenics, Inc.'s devices?
Among its 3 most recently registered devices, Igenics, Inc. has devices listed in FDA 510(k) (3 devices).
What are the newest devices from Igenics, Inc. in the registry?
The most recently registered devices listed for Igenics, Inc. include SYNTHETIC SPONGE, GENERAL USE SYNTHETIC SPONGE (STERILE) and DRAIN/SLIT SPONGE (NON-STERILE AND STERILE).