AOMORI OLYMPUS CO., Ltd. Kuroishi Site
KUROISHI-SHI Aomori, JP
AOMORI OLYMPUS CO., LTD. Kuroishi Site appears in FDA device records in KUROISHI-SHI Aomori, JP. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 113 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to AOMORI OLYMPUS CO., Ltd. Kuroishi Site carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Aomori Olympus Co., Ltd.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for AOMORI OLYMPUS CO., Ltd. Kuroishi Site between 2003 and 2005. The busiest year on record is 2003, with 5. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 5 |
| 2004 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042160 | SONOSURG TROCAR | LFL | Substantially Equivalent | |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | |
| K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B | FGE | Substantially Equivalent | |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | |
| K021672 | PANCREATIC DRAINAGE TUBE | FGE | Substantially Equivalent | |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | EOQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614641 | 3003995201 | AOMORI OLYMPUS CO., LTD. Kuroishi Site | 2-248-1 OKKONOKI, KUROISHI-SHI Aomori 036-0357 JP | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- QGEBiliary Stent, Drain, And Dilator Accessories
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- KTIBronchoscope Accessory
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- LQRDislodger, Stone, Biliary
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- KGEForceps, Biopsy, Electric
- QECForceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
- FDSGastroscope And Accessories, Flexible/Rigid
- PKLHemostatic Metal Clip For The Gi Tract
- LFLInstrument, Ultrasonic Surgical
- GCJLaparoscope, General & Plastic Surgery
- MNDLigator, Esophageal
- LQCLithotriptor, Biliary Mechanical
- EOBNasopharyngoscope (Flexible Or Rigid)
- GAANeedle, Aspiration And Injection, Disposable
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- FGEStents, Drains And Dilators For The Biliary Ducts
- ITXTransducer, Ultrasonic, Diagnostic
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
Showing 25 of 113| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2523-2023 | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666 | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 | Class II | Open, Classified | |
| Z-2522-2023 | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012 | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 | Class II | Open, Classified | |
| Z-1071-2021 | CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1070-2021 | CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1069-2021 | NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1068-2021 | MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1067-2021 | MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1066-2021 | PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1065-2021 | PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1064-2021 | PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1063-2021 | PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1062-2021 | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1061-2021 | NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1060-2021 | NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1059-2021 | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1058-2021 | NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1057-2021 | NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1056-2021 | NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1055-2021 | NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1054-2021 | NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1053-2021 | K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1052-2021 | K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1051-2021 | K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1050-2021 | K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated | |
| Z-1049-2021 | NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain