Surgilite Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Surgilite Intl., Inc. makes
Surgilite Intl., Inc. manufactures single-use surgical textiles, including non-woven wraps for wound protection, multiple-use surgical masks, scrub suits for sterile procedures, and laparotomy sponges for surgical absorption. Their product line also includes no-gauze variants of laparotomy sponges, designed for specific surgical applications.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with several products subject to 510(k) clearance. Their products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Surgilite Non-Woven Wrap Ref K822482
Regimes: 510(k) Registry: 510(k)Multiple Surgical Mask Ref K822481
Regimes: 510(k) Registry: 510(k)Multiple Scrub Suit Ref K822483
Regimes: 510(k) Registry: 510(k)Laparotomy Sponges Ref K771531
Regimes: 510(k) Registry: 510(k)No-Gauze Laparotomy Sponge Ref K823671
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgilite Intl., Inc. have in the registry?
The registry currently lists 5 devices for Surgilite Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgilite Intl., Inc.'s devices?
Among its 5 most recently registered devices, Surgilite Intl., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Surgilite Intl., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Surgilite Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgilite Intl., Inc. in the registry?
The most recently registered devices listed for Surgilite Intl., Inc. include SURGILITE NON-WOVEN WRAP, MULTIPLE SURGICAL MASK, MULTIPLE SCRUB SUIT and LAPAROTOMY SPONGES.