Medical Device Manufacturer · US , Southborough , MA

Olympus Surgical Technologies America - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2012
12
Total
12
Cleared
0
Denied

Olympus Surgical Technologies America has 12 FDA 510(k) cleared medical devices. Based in Southborough, US.

Latest FDA clearance: Aug 2024. Active since 2012. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Olympus Surgical Technologies America Filter by specialty or product code using the sidebar.

12 devices
1–12 of 12
SOLTIVE? Laser System (SOLTIVE? Pro SuperPulsed Laser, SOLTIVE? Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
K242191 · GEX Powered Laser Surgical Instrument · Gastroenterology & Urology
Aug 2024 29d
POWERSEAL Curved Jaw Sealer and Divider, Double Action
K212643 · GEI Electrosurgical, Cutting & Coagulation & Accessories · General & Plastic Surgery
Sep 2021 38d
ViziShot 2 FLEX
K193517 · KTI Bronchoscope Accessory · Anesthesiology
Mar 2020 90d
SOLTIVE? Laser System(SOLTIVE? Pro SuperPulsed Laser, SOLTIVE? Premium SuperPulsed Laser, SOLTIVE?Laser Fibers, and Accessories)
K183647 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Aug 2019 226d
CleverLock Guidewire Locking Device and Biopsy Cap
K190164 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Apr 2019 63d
PeriView FLEX
K181193 · KTI Bronchoscope Accessory · Ear, Nose, Throat
Jul 2018 60d
PeriView FLEX
K171232 · KTI Bronchoscope Accessory · Ear, Nose, Throat
Sep 2017 147d
ViziShot 2 FLEX
K163469 · KTI Bronchoscope Accessory · Ear, Nose, Throat
Apr 2017 115d
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
K143609 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology
Mar 2015 98d
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
K132181 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
Oct 2013 98d
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
K123170 · KNY Accessories, Catheter, G-u · Gastroenterology & Urology
Feb 2013 118d
GYRUS ACMI BICOAG HEMOSTASIS PROBE
K123319 · KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · Gastroenterology & Urology
Dec 2012 49d
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All12 Gastroenterology & Urology 6 Ear, Nose, Throat 3 General & Plastic Surgery 2 Anesthesiology 1