Gallini U.S., LLC
United StatesFDA applicant, unverified
- Devices
- 10
What Gallini U.S., LLC makes
Gallini U.S., LLC manufactures biopsy and aspiration devices including coaxial introducers, automatic biopsy systems, bone marrow aspiration and biopsy needles, and various specialized needles such as the Spigal needle, IBI, Atra-Cut needle, Bycut needle, and ACRI R needle.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; Gallini U.S., LLC is based in the United States.
Catalogue
Gallini Coaxial Introducer Ref K972266
Regimes: 510(k) Registry: 510(k)Quick-Cut Automatic Biopsy System Ref K980479
Regimes: 510(k) Registry: 510(k)Gallini Abs Device Ref K973152
Regimes: 510(k) Registry: 510(k)Spigal Needle Ref K980676
Regimes: 510(k) Registry: 510(k)Ibi Ref K974440
Regimes: 510(k) Registry: 510(k)Gallini Atra-Cut Needle Ref K990645
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Gallini Bycut Needle Ref K990716
Regimes: 510(k) Registry: 510(k)Speed-Cut Automatic Biopsy System Ref K981301
Regimes: 510(k) Registry: 510(k)Acri R Needle Ref K980248
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gallini U.S., LLC have in the registry?
The registry currently lists 10 devices for Gallini U.S., LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gallini U.S., LLC's devices?
Among its 10 most recently registered devices, Gallini U.S., LLC has devices listed in FDA 510(k) (10 devices).
What risk classes do Gallini U.S., LLC's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Gallini U.S., LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gallini U.S., LLC in the registry?
The most recently registered devices listed for Gallini U.S., LLC include GALLINI COAXIAL INTRODUCER, QUICK-CUT AUTOMATIC BIOPSY SYSTEM, GALLINI ABS DEVICE and SPIGAL NEEDLE.