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

Endovations — Predicate Candidate Screening

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

89 daysmedian FDA review time

158 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K955413	ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER	Endovations	1996-02-08	73	0
K942110	INJECT-SNARE	Endovations	1994-10-13	164	0
K934315	ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME	Endovations	1994-02-28	180	0
K913841	2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH	Endovations	1991-10-08	43	0
K913870	5MM MICROSCISSORS	Endovations	1991-09-16	18	0
K911155	OVAL CUP BIOPSY FORCEP	Endovations	1991-08-07	145	0
K892218	ENDO-SPONGE	Endovations	1989-05-31	58	0
K883093	TRANSENDOSCOPIC ASPIRATION NEEDLE	Endovations	1988-12-08	139	0
K873360	ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG	Endovations	1988-03-30	222	0
K875264	WASHING CATHETER	Endovations	1988-03-29	98	0
K874062	ENTERON LIVER BIOPSY TRAY	Endovations	1987-12-31	87	0
K874016	OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO	Endovations	1987-12-29	89	0
K874012	OVAL CUP BIOPSY FORCEP (MODEL 18/5)	Endovations	1987-12-29	89	0
K874006	GRASPING TRIPOD FORCEP (MODEL 23/25)	Endovations	1987-12-29	89	0
K874004	ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)	Endovations	1987-12-29	89	0
K874003	HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)	Endovations	1987-12-29	89	0
K874005	RAT TOOTH GRASPING FORCEP (MODEL 23/20)	Endovations	1987-12-29	89	0
K874009	OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)	Endovations	1987-12-29	89	0
K874010	ROUND CUP HOT BIOPSY FORCEP (MODEL D-52)	Endovations	1987-12-29	89	0
K874008	OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)	Endovations	1987-12-29	89	0
K874007	OVAL CUP HOT BIOPSY FORCEP (MODEL A-51)	Endovations	1987-12-29	89	0
K874014	OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)	Endovations	1987-12-29	89	0
K874239	CLEANING BRUSH	Endovations	1987-12-29	74	0
K874013	OVAL CUP BIOPSY FORCEP(23/5) USED W/COLONOSCOPE	Endovations	1987-12-29	89	0
K874011	OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)	Endovations	1987-12-29	89	0
K874015	HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12)	Endovations	1987-12-29	89	0
K874164	GUIDE WIRE	Endovations	1987-12-07	55	0
K874063	ENTERON ABDOMINAL PARACENTESIS TRAY	Endovations	1987-12-04	60	1
K872060	WASHING/INJECTION NEEDLE	Endovations	1987-07-21	54	0
K871315	ORAL ASPIRATOR	Endovations	1987-04-15	14	0
K862059	SHEATH, ENDOSCOPE	Endovations	1986-11-04	158	0
K862424	STEERABLE CATHETER SYSTEM	Endovations	1986-09-22	88	0
K862058	RAPID ENDOSCOPIC LAVAGE SYSTEM	Endovations	1986-08-11	73	0
K862060	POLYPECTOMY SNARE	Endovations	1986-06-27	28	0
K860990	ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY	Endovations	1986-05-13	57	0
K860991	SCLEROTHERAPY INJECTION CATHETER	Endovations	1986-05-02	46	0
K860997	GASTROINTESTINAL CYTOLOGY BRUSH	Endovations	1986-05-02	45	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