Company ยท US
Olympus America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2012. Name variants (Inc, Corp, punctuation) are merged.
149510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 11 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 10 |
| HET | Laparoscope, Gynecologic (And Accessories) | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 6 |
| FCG | Biopsy Needle | 4 |
| JIT | Calibrator, Secondary | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| LQC | Lithotriptor, Biliary Mechanical | 4 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 4 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 |
| HIH | Hysteroscope (And Accessories) | 3 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 |
| LMB | Device, Digital Image Storage, Radiological | 3 |
| MND | Ligator, Esophageal | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2012 | K111788 | ENDOEYE HD II Olympus America, Inc. | HET |
| Mar 18, 2009 | K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN Olympus America, Inc., IE | DHX |
| Feb 11, 2008 | K073490 | OLYMPUS IGG REAGENT Olympus America, Inc., IE | CFN |
| Feb 11, 2008 | K073489 | OLYMPUS IGA REAGENT Olympus America, Inc., IE | CFN |
| Feb 11, 2008 | K073487 | OLYMPUS IGM REAGENT Olympus America, Inc., IE | CFN |
| Apr 6, 2007 | K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 Olympus America, Inc. | KNK |
| Mar 23, 2007 | K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM Olympus America, Inc. | CDT |
| Jan 26, 2007 | K061499 | OSFERION Olympus America, Inc. | MQV |
| Nov 29, 2006 | K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM Olympus America, Inc. | JLW |
| Oct 5, 2006 | K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 Olympus America, Inc. | CJY |
| Jun 6, 2006 | K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. Olympus America, Inc. | DHR |
| Aug 22, 2005 | K051564 | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH Olympus America, Inc. | NQD |
| Jul 1, 2005 | K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE Olympus America, Inc. | FDF |
| Jan 31, 2005 | K043460 | OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 Olympus America, Inc. | JIX |
| Dec 23, 2004 | K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 Olympus America, Inc. | CGS |
| Dec 3, 2004 | K042406 | OLYMPUS LACTATE, OSR6193 Olympus America, Inc. | JIT |
| Aug 19, 2004 | K041668 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | NQD |
| Jul 16, 2004 | K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 Olympus America, Inc. | JMO |
| Apr 8, 2004 | K040692 | OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 Olympus America, Inc. | JIT |
| Mar 10, 2004 | K040471 | OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 Olympus America, Inc. | JIT |
| Nov 21, 2003 | K032665 | OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 Olympus America, Inc. | JIX |
| Nov 14, 2003 | K031380 | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) Olympus America, Inc. | LCP |
| Aug 21, 2003 | K032285 | OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 Olympus America, Inc. | JIT |
| Feb 21, 2003 | K030045 | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) Olympus America, Inc. | DIH |
| Feb 6, 2003 | K030124 | OLYMPUS FERRITIN REAGENT Olympus America, Inc. | DBF |
| May 2, 2002 | K021074 | VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA Olympus America, Inc. | FAJ |
| May 1, 2002 | K021073 | VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V Olympus America, Inc. | EOB |
| Feb 8, 2002 | K014032 | OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA Olympus America, Inc. | LBS |
| Feb 8, 2002 | K014015 | OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA Olympus America, Inc. | LBS |
| Dec 11, 2001 | K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE Olympus America, Inc. | MND |
| Aug 27, 2001 | K011886 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, Olympus America, Inc. | ODG |
| Jun 25, 2001 | K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | CIX |
| Feb 27, 2001 | K001744 | OLYMPUS ENDOSCOPIC LIGATION DEVICE Olympus America, Inc. | MND |
| Dec 18, 2000 | K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | JJE |
| Oct 25, 2000 | K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | JJE |
| Oct 25, 2000 | K002918 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | DCN |
| Sep 5, 2000 | K994103 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT Olympus America, Inc. | ITX |
| Jun 2, 2000 | K994106 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE Olympus America, Inc. | ITX |
| Jun 2, 2000 | K994069 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE Olympus America, Inc. | ITX |
| Nov 3, 1999 | K991672 | OLYMPUS NA-10J-KB ASPIRATION NEEDLE Olympus America, Inc. | FCG |
| Sep 17, 1999 | K984358 | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 Olympus America, Inc. | FDS |
| Aug 19, 1999 | K992086 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 Olympus America, Inc. | JIX |
| Jul 12, 1999 | K990237 | TROCAR SYSTEM ACCORDING TO HASSON Olympus America, Inc. | GCJ |
| May 11, 1999 | K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM Olympus America, Inc. | JZG |
| Feb 24, 1999 | K984417 | BIPOLAR GRASPING FORCEPS BIQ+ Olympus America, Inc. | GEI |
| Dec 11, 1998 | K982323 | OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE Olympus America, Inc. | ITX |
| Oct 23, 1998 | K982725 | OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE Olympus America, Inc. | ITX |
| Aug 19, 1998 | K982289 | HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## Olympus America, Inc. | KNS |
| Jun 9, 1998 | K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | CKB |
| May 7, 1998 | K981305 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR Olympus America, Inc. | JIX |
Newest 50 of 149.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2015 | Olympus America Inc. EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy Terminated |
FDT | K080403 |
| Dec 5, 2013 | Olympus America Inc. TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-05 Terminated |
GEI | K111202 |
| Nov 15, 2013 | Olympus America Inc. Olympus Endoscopic Flushing Pump, Model OPF-2.
Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures. Terminated |
FEQ | K100899 |
| May 8, 2013 | Olympus America Inc. Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")
Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) Terminated |
KNS | K030194 |
| Mar 5, 2012 | Olympus America Inc. Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1
The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has Terminated |
FEM | None listed |
| Jan 20, 2012 | Olympus America Inc. Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A.
Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive Terminated |
KNS | K030194 |
| Jan 20, 2012 | Olympus America Inc. Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A.
Working element for endoscopic diagnosis and treatment in urological and gynecological applications. Terminated |
KNS | K030194 |
| Jan 18, 2012 | Olympus America Inc. Olympus OFP Flushing Pump irrigation tubing
The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as Terminated |
FEQ | K000948 |
| Jan 13, 2012 | Olympus America Inc. Olympus Electrosurgical Unit.
The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures duri Terminated |
GEI | K073207 |
| Oct 7, 2011 | Olympus America Inc. OLYMPUS ViziShot EBUS Aspiration Needle
Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically Terminated |
FCG | K050503 |
| Aug 31, 2011 | Olympus America Inc. OLYMPUS Pediatric Knives and Resection Electrodes
The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral Terminated |
EZO | K904939 |
| Oct 1, 2010 | Olympus America Inc. Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment) Terminated |
GCJ | None listed |
| Aug 18, 2010 | Olympus America Inc. Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15.
To be used with Ol Terminated |
FDI | K955650 |
| Mar 18, 2010 | Olympus America Inc. Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L
Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscop Terminated |
KOG | K790071 K923982 |
| Oct 31, 2007 | Olympus America Inc. Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc. Terminated |
LQC | K903529 |
| Oct 31, 2007 | Olympus America Inc. Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, Inc. Terminated |
LQC | K903529 |
| Oct 31, 2007 | Olympus America Inc. Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America, Inc. Terminated |
LQC | K903529 |
| Oct 31, 2007 | Olympus America Inc. Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc. Terminated |
LQC | K903529 |
| Dec 23, 2005 | Olympus America, Inc OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympu Terminated |
JQP | None listed |
| Oct 15, 2003 | Olympus America Inc. Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8)
Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software Terminated |
LMB | K934888 K934889 |
| Aug 12, 2003 | Olympus America Inc. Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt. Terminated |
LMB | K934888 K934889 |