LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP— 510(k) K090830

Clearance details

Applicant

Laborie Medical Technologies, Ltd.

Product code

Code FBK

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2009-03-26

Decision date

2009-07-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Williston, VT, US

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Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1478-2023 — injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gaugeClass II·Ongoing·Labories Medical Technologies·20230207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090830.