Company ยท US
Gallini U.S., LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 1999. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNW | Instrument, Biopsy | 10 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 1999 | K992499 | GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE Gallini U.S., LLC | KNW |
| May 19, 1999 | K990645 | GALLINI ATRA-CUT NEEDLE Gallini U.S., LLC | KNW |
| May 17, 1999 | K990716 | GALLINI BYCUT NEEDLE Gallini U.S., LLC | KNW |
| Jul 8, 1998 | K981301 | SPEED-CUT AUTOMATIC BIOPSY SYSTEM Gallini U.S., LLC | KNW |
| May 21, 1998 | K980676 | SPIGAL NEEDLE Gallini U.S., LLC | KNW |
| May 6, 1998 | K980479 | QUICK-CUT AUTOMATIC BIOPSY SYSTEM Gallini U.S., LLC | KNW |
| Feb 18, 1998 | K980248 | ACRI R NEEDLE Gallini U.S., LLC | KNW |
| Jan 30, 1998 | K974440 | IBI Gallini U.S., LLC | KNW |
| Jan 9, 1998 | K973152 | GALLINI ABS DEVICE Gallini U.S., LLC | KNW |
| Jul 29, 1997 | K972266 | GALLINI COAXIAL INTRODUCER Gallini U.S., LLC | KNW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||