Jain Surgical Equipment, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Jain Surgical Equipment, Inc. makes
Jain Surgical Equipment, Inc. manufactures surgical tools and accessories designed to streamline surgical workflows, including suture organizers, graft preparation aids, and blood management devices. The JAIN SUTURE/VESIBAND ORGANIZER helps organize and secure sutures and vascular bands, while the JAIN GRAFT ASSIST assists in preparing vascular grafts. The JAIN QUICK COUNT and JAIN SUTURE PACKAGE COUNTER track suture counts, and the JAIN BLOOD SHIELD is used to manage blood during surgical procedures.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) clearance registry, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Jain Suture/Vesiband Organizer Ref K905105
Regimes: 510(k) Registry: 510(k)Jain Graft Assist Ref K904536
Regimes: 510(k) Registry: 510(k)Jain Quick Count Ref K911076
Regimes: 510(k) Registry: 510(k)Jain Blood Shield Ref K913896
Regimes: 510(k) Registry: 510(k)Jain Suture Package Counter Ref K911077
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Jain Surgical Equipment, Inc. have in the registry?
The registry currently lists 5 devices for Jain Surgical Equipment, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jain Surgical Equipment, Inc.'s devices?
Among its 5 most recently registered devices, Jain Surgical Equipment, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Jain Surgical Equipment, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Jain Surgical Equipment, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jain Surgical Equipment, Inc. in the registry?
The most recently registered devices listed for Jain Surgical Equipment, Inc. include JAIN SUTURE/VESIBAND ORGANIZER, JAIN GRAFT ASSIST, JAIN QUICK COUNT and JAIN BLOOD SHIELD.