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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sutter Medizintechnik GmbH · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
246 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251813CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH2026-02-112430
K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTSutter Medizintechnik GmbH2024-01-251060
K193587Sutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH2020-02-10490
K192128Sutter Arrowtip Monopolar ElectrodesSutter Medizintechnik GmbH2019-10-04580
K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH2019-08-30630
K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH2018-02-232460
K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH2015-09-101530
K131012SUTTER BIPOLAR FORCEPS - SUPERGLISSSutter Medizintechnik GmbH2013-08-231340
K073450SUTTER ELECTROSURGICAL CABLESSutter Medizintechnik GmbH2008-03-17980

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda