STIMULAN KIT, STIMULAN RAPID CURE— 510(k) K141830

Clearance details

Applicant

Biocomposites, Ltd.

Product code

Code MQV

Device class

Class 2

Regulation

21 CFR 888.3045

Advisory panel

Orthopedic

Date received

2014-07-07

Decision date

2015-01-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Keele, GB

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Death

6

Injury

435

Total

441

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-0638-2021 — Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.Class II·Terminated·Biocomposites, Ltd.·20201112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141830.