Company ยท US
Olympus Corporation of the Americas
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2014. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
423recalls (122 in 12 months)
404recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 100 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 39 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 27 |
| LFL | Instrument, Ultrasonic Surgical | 25 |
| FEB | Accessories, Cleaning, For Endoscope | 21 |
| GEX | Powered Laser Surgical Instrument | 20 |
| FJL | Resectoscope | 19 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | 17 |
| JAK | System, X-Ray, Tomography, Computed | 15 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 14 |
| KQT | Evacuator, Gastro-Urology | 10 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 9 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 7 |
| FEO | Lithotriptor, Ultrasonic | 7 |
| HIH | Hysteroscope (And Accessories) | 7 |
| HIF | Insufflator, Laparoscopic | 6 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 5 |
| GCP | Endoscope, Ac-Powered And Accessories | 5 |
| HET | Laparoscope, Gynecologic (And Accessories) | 5 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 5 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | Olympus Corporation of the Americas Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System Open, Classified |
N/A | None listed |
| Sep 25, 2026 | Olympus Corporation of the Americas Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A. Open, Classified |
HIH | K890328 |
| Sep 25, 2026 | Olympus Corporation of the Americas Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A. Open, Classified |
HIH | K890328 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. Open, Classified |
FGE | None listed |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. Open, Classified |
KNS | K123319 |
| Aug 26, 2026 | Olympus Corporation of the Americas POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.
GEI / Electrosurgical, cutting & coagulation & accessories Open, Classified |
GEI | K212643 |
| Jul 22, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Open, Classified |
HIF | K243527 |
| Jul 20, 2026 | Olympus Corporation of the Americas Olympus 4K UHD LCD Monitor. Model Number: OEV321UH.
An electrically powered visual display unit designed for displaying graphical information in color. Open, Classified |
GCJ | K220069 |
| Jul 10, 2026 | Olympus Corporation of the Americas Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. Open, Classified |
KQT | None listed |
| Jul 10, 2026 | Olympus Corporation of the Americas Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194. Open, Classified |
KQT | K890328 |
| Jul 10, 2026 | Olympus Corporation of the Americas Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. Open, Classified |
KQT | None listed |
| Jul 10, 2026 | Olympus Corporation of the Americas Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. Open, Classified |
KQT | None listed |
| Jul 7, 2026 | Olympus Corporation of the Americas Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the in Open, Classified |
FDT | K220587 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 Open, Classified |
FEB | K201920 |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110.
May be included with the Olympus OER-ELITE. Open, Classified |
FEB | K201920 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. Open, Classified |
GEI | K252150 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. Open, Classified |
GEI | K252150 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. Open, Classified |
GEI | K252150 |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. Open, Classified |
GEI | K252150 |
| Mar 30, 2026 | Olympus Corporation of the Americas Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System
Product Name: SOLTIVE Pro Laser System TFL-SLS
Model/Catalog Number: TFL-SLS containing TFL-CSLU
Product Description: An electricity powered de Open, Classified |
GEX | K242191 |
| Mar 30, 2026 | Olympus Corporation of the Americas Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System
Product Name: SOLTIVE Premium Laser System TFL-PLS
Model/Catalog Number: TFL-PLS containing TFL-CPLU
Product Description: An electricity po Open, Classified |
GEX | K242191 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm
Product Name: PKS Cutting Forceps
Model/Catalog Number: 920005PK
Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm
Product Name: PKS Cutting Forceps
Model/Catalog Number: 920000PK
Product Description: The PKS Cutting Forceps are intended to be passed through Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm
Product Name: PKS Cutting Forceps
Model/Catalog Number: 3005PK
Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm ca Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm
Product Name: HALO PKS Cutting Forceps
Model/Catalog Number: HACF0533
Product Description: The HALO PKS Cutting Forceps are intended to be passed Open, Classified |
GEI | K100896 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus PK Cutting Forceps, 5mm 33cm
Product Name: PK Cutting Forceps
Model/Catalog Number: PK-CF0533
Product Description: An assembly of devices intended to generate and apply radio-frequ Open, Classified |
GEI | K203277 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm
Product Name: Everest Bipolar Cutting Forceps
Model/Catalog Number: 3006
Product Description: The OLYMPUS Everest Bipolar Cutting Open, Classified |
GEI | K023492 |
| Mar 25, 2026 | Olympus Corporation of the Americas Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm
Product Name: Everest Bipolar Cutting Forceps
Model/Catalog Number: 3005
Product Description: The OLYMPUS Everest Bipolar Cutting Forcep Open, Classified |
GEI | K023492 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. Open, Classified |
FEB | K103264 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. Open, Classified |
FEB | K201920 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. Open, Classified |
ODC | K250949 |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. Open, Classified |
ODC | K250949 |
| Mar 5, 2026 | Olympus Corporation of the Americas Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator
Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes
Model/Catalog Number: SPL-SR, contains generator SPL-G
Product Des Open, Classified |
FEO | K171024 |
| Mar 3, 2026 | Olympus Corporation of the Americas Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box.
The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent lea Open, Classified |
EOQ | K061313 |
| Mar 3, 2026 | Olympus Corporation of the Americas Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box.
The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflu Open, Classified |
EOQ | K061313 |
| Feb 27, 2026 | Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System
Product Name: ShockPulse-SE Lithotripsy System - Generator
Model/Catalog Number: SPL-G
Product Description: The ShockPulse Lithotripsy System is an electro Open, Classified |
FEO | K171024 |
| Feb 27, 2026 | Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System SPL-S
Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes
Model/Catalog Number: SPL-S
Product Description: The ShockPulse Lithotripsy System Open, Classified |
FEO | K171024 |
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