STIMUPLEX HNS-12, MODEL 4892098— 510(k) K052313

Clearance details

Applicant

Stockert GmbH

Product code

Code BXN

Device class

Class 2

Regulation

21 CFR 868.2775

Advisory panel

Anesthesiology

Date received

2005-08-25

Decision date

2005-11-17

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Freiburg, B-W, DE

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• K140853 — STIMPOD ST2-3010 NERVE STIMULATOR2014-11-06

• K070336 — STOCKERT NEURO N50, MODEL122672007-06-14
• K070134 — MODIFICATION TO STIMUPLEX HNS-12, MODEL 48920982007-03-22
• K061983 — STIMUPLEX PEN2006-11-21
• K003983 — STIMUPLEX HNS-112001-06-06

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 →