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

Karl Storz Endoscopy — Predicate Candidate Screening

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

81 daysmedian FDA review time

302 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K043375	FISCH TITANIUM MIDDLE EAR PROSTHESES	Karl Storz Endoscopy	2005-01-24	47	0
K030848	PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX	Karl Storz Endoscopy	2003-06-02	77	0
K030009	KSEA POWERSHAVER SYSTEM S2	Karl Storz Endoscopy	2003-04-02	90	1
K023924	AUTOCON II 200 ELECTROSURGICAL GENERATOR	Karl Storz Endoscopy	2003-02-21	88	0
K023187	KSEA SPINOSCOPE	Karl Storz Endoscopy	2002-12-02	69	0
K011700	MODULITH SLK LITHOTRIPTER	Karl Storz Endoscopy	2002-08-16	441	0
K021776	KSEA QUADRO SWITCH	Karl Storz Endoscopy	2002-08-15	78	0
K013107	BIOABSORBABLE INTERFERENCE SCREW MEGAFIX	Karl Storz Endoscopy	2002-02-26	162	0
K011841	KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR	Karl Storz Endoscopy	2001-09-10	90	0
K010569	KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION	Karl Storz Endoscopy	2001-04-09	42	0
K004037	X-RAY SYSTEM XR-MX	Karl Storz Endoscopy	2001-02-02	36	0
K001630	KSEA BIPOLAR COAGULATING ELECTRODES	Karl Storz Endoscopy	2000-07-19	54	0
K992469	KSEA SCBCOM	Karl Storz Endoscopy	1999-10-15	81	0
K992027	KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIP	Karl Storz Endoscopy	1999-09-09	85	0
K992541	LAPAROCAM	Karl Storz Endoscopy	1999-08-19	20	0
K992114	KSEA CALCUSPLIT	Karl Storz Endoscopy	1999-08-18	57	0
K991228	DCI ENDOSCOPE	Karl Storz Endoscopy	1999-06-23	72	0
K991171	DCI ENDOSCOPE	Karl Storz Endoscopy	1999-06-23	77	0
K990411	MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE	Karl Storz Endoscopy	1999-05-11	90	0
K983142	KSEA C-MOUNT ARTHROSCOPES	Karl Storz Endoscopy	1998-12-07	90	0
K982837	KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSC	Karl Storz Endoscopy	1998-11-06	86	0
K982905	MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE	Karl Storz Endoscopy	1998-10-05	48	0
K981703	KSEA UNIMAT 45	Karl Storz Endoscopy	1998-08-12	90	0
K981458	KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBE	Karl Storz Endoscopy	1998-05-20	27	1
K972488	KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES	Karl Storz Endoscopy	1998-01-22	204	0
K974366	KSEA PLASTIC TROCARS	Karl Storz Endoscopy	1998-01-08	49	0
K963423	KSEA CO2 ENDOFLATOR	Karl Storz Endoscopy	1997-05-27	270	0
K970427	KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE	Karl Storz Endoscopy	1997-03-11	35	0
K963524	KSEA LARGE JOINT ARTHROSCOPY SET	Karl Storz Endoscopy	1996-11-14	71	0
K960486	KSEA MODEL 383320 20 ANGIOMAT	Karl Storz Endoscopy	1996-10-25	266	0
K962881	KSEA CULDOCENTESIS SET	Karl Storz Endoscopy	1996-10-22	90	0
K953109	HAND EXTRACTOR HECTOR	Karl Storz Endoscopy	1995-08-25	53	0
K943052	ARTHROSCOPIC TELESCOPES	Karl Storz Endoscopy	1995-05-25	332	0
K942112	KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE	Karl Storz Endoscopy	1995-02-28	302	0
K936231	THE KARL STORZ HAMOU ENDOMAT	Karl Storz Endoscopy	1995-01-24	391	0

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