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

Karl Storz Endoskop GmbH · Predicate Candidate Screening

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

64 daysmedian FDA review time
267 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973068KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTINGKarl Storz Endoskop GmbH1997-11-07810
K961702KSEA VAPORIZATION ELECTRODESKarl Storz Endoskop GmbH1996-08-291190
K953368LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBESKarl Storz Endoskop GmbH1995-09-18620
K943713TORCARS,CANNULAE,SHEATHS,OBTURATORSKarl Storz Endoskop GmbH1995-06-303330
K951995KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTORKarl Storz Endoskop GmbH1995-05-24260
K943053KSEA SEMM TISSUR PUNCHKarl Storz Endoskop GmbH1995-03-212670
K943435CHOLANGIOGRAPHY SETKarl Storz Endoskop GmbH1994-11-071120
K944823KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION Karl Storz Endoskop GmbH1994-11-02340
K943904RIGID TELESCOPESKarl Storz Endoskop GmbH1994-10-14640
K943697TROCARS,CANNULAE,SHEATHS,OBTURATORSKarl Storz Endoskop GmbH1994-09-14470
K943816TROCARS,CANNULAE, SHEATHSKarl Storz Endoskop GmbH1994-08-24190

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