Medical Device Manufacturer · US , Mchenry , IL

Primrose Medical, Inc.

14 submissions · 14 cleared · Since 1984
14
Total
14
Cleared
0
Denied

Primrose Medical, Inc. — FDA 510(k) Submissions

Primrose Medical, Inc. has submitted 14 FDA 510(k) premarket notifications since 1984, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dilator, Esophageal, Infusor, Pressure, For I.v. Bags, Tubes, Gastrointestinal (and Accessories), Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
URETHRAL AND URETERAL BALLOON DILATATORS
K884711 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
Sep 1989 325d
COLONIC BALLOON DIALATORS
K884713 · FFP Dilator, Rectal · Gastroenterology & Urology
Sep 1989 325d
BILIARY DIALATOR
K884714 · FGE Stents, Drains And... · Gastroenterology & Urology
Sep 1989 325d
ACHELASIA BALLOON DIALATOR
K884715 · KNQ Dilator, Esophageal · Gastroenterology & Urology
Sep 1989 325d
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
K884709 · ODD Endoscopic Retrograde... · Gastroenterology & Urology
Sep 1989 304d
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
K884712 · KNQ Dilator, Esophageal · Gastroenterology & Urology
Sep 1989 304d
LANCET, BLOOD
K883420 · FMK Single Use Only Blood... · General & Plastic Surgery
Aug 1988 11d
CATHETER, INTRAVASCULAR
K881976 · FOZ Catheter, Intravascular,... · General Hospital
Aug 1988 85d
SET, INTRAVASCULAR
K881975 · FPA Set, Administration,... · General Hospital
Jul 1988 79d
PRESSURE INFUSOR
K881977 · KZD Infusor, Pressure, For... · General Hospital
Jul 1988 79d
ENTERAL FEEDING TUBES
K881978 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jul 1988 63d
NINJA SCALPEL
K873493 · GES Blade, Scalpel · General & Plastic Surgery
Sep 1987 24d
ESOPHAGEAL STETHOSCOPES
K843070 · BZW Stethoscope, Esophageal · Anesthesiology
Aug 1984 18d
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
K843071 · BZT Stethoscope, Esophageal,... · Anesthesiology
Aug 1984 18d
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