Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Guenter Bissinger Medizintechnik GmbH · Predicate Candidate Screening

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

86 daysmedian FDA review time
430 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213042Supra Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH2022-11-174210
K150024Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH2015-02-20440
K051429CLARIS NON-STICK BIPOLAR FORCEPSGuenter Bissinger Medizintechnik GmbH2005-07-29580
K042077BITECH BIPOLAR SCISSORSGuenter Bissinger Medizintechnik GmbH2004-10-27860
K981919BISSINGER CABLES, CAT. NO. 801000XXGuenter Bissinger Medizintechnik GmbH1998-08-06660
K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPSGuenter Bissinger Medizintechnik GmbH1998-05-214300

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