Medical Device Manufacturer · US , Camp Hill , PA

Endovations

37 submissions · 36 cleared · Since 1986
37
Total
36
Cleared
0
Denied

Endovations — FDA 510(k) Submissions

Endovations has submitted 37 FDA 510(k) premarket notifications since 1986, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Endoscopic Grasping/cutting Instrument, Non-powered, Stents, Drains And Dilators For The Biliary Ducts, Tubes, Gastrointestinal (and Accessories), Accessories, Cleaning Brushes, For Endoscope, Endoscopic Irrigation/suction System . Use the specialty filter in the sidebar to narrow results.

37 devices
1–12 of 37
ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
K955413 · FGE Stents, Drains And... · Gastroenterology & Urology
Feb 1996 73d
INJECT-SNARE
K942110 · FDI Snare, Flexible · Gastroenterology & Urology
Oct 1994 164d
ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME
K934315 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Feb 1994 180d
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
K913841 · FGE Stents, Drains And... · Gastroenterology & Urology
Oct 1991 43d
5MM MICROSCISSORS
K913870 · GCJ Laparoscope, General &... · General & Plastic Surgery
Sep 1991 18d
OVAL CUP BIOPSY FORCEP
K911155 · FCF Instrument, Biopsy,... · Gastroenterology & Urology
Aug 1991 145d
ENDO-SPONGE
K892218 · MNL Accessories, Cleaning... · Gastroenterology & Urology
May 1989 58d
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · FBK Endoscopic Injection... · Gastroenterology & Urology
Dec 1988 139d
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
K873360 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Mar 1988 222d
WASHING CATHETER
K875264 · OCX Endoscopic... · Gastroenterology & Urology
Mar 1988 98d
ENTERON LIVER BIOPSY TRAY
K874062 · KNW Instrument, Biopsy · Gastroenterology & Urology
Dec 1987 87d
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)
K874003 · OCZ Endoscopic... · Gastroenterology & Urology
Dec 1987 89d

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