510(k) K090830 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
| Applicant | Laborie Medical Technologies, Ltd., Williston VT, US |
| Decision | Substantially Equivalent, Jul 21, 2009 |
| Received | Mar 26, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2023 | Labories Medical Technologies injeTAK Adjustable Tip Needles
Needle Sheath diameter 6Fr with 35-50cm in length
Stainless-stell needle cannula is 25 gauge Open, Classified |
FBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.