510(k) Report

FDA applicant

Select Medizintechnik Hermann Sutter GmbH

Roswell, GA1 decision1999–19990 recalls

FDA records 1 decision for Select Medizintechnik Hermann Sutter GmbH (Roswell, GA) in 1999: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Select Medizintechnik Hermann Sutter GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Select Medizintechnik Hermann Sutter GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Select Medizintechnik Hermann Sutter GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Select”

FDA records each applicant name separately; these may or may not be the same firm.