Aomori Olympus Co., Ltd.
FDA Regulatory Profile
Aomori Olympus Co., Ltd. appears in FDA public data with 113 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2523-2023, Class II) was initiated on July 27, 2023. Its most recent 510(k) clearance was granted on January 25, 2005.
Summary
- Total Recalls
- 113
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2523-2023 | Class II | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588 | July 27, 2023 |
| Z-2522-2023 | Class II | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end | July 27, 2023 |
| Z-1005-2021 | Class II | INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to per | January 4, 2021 |
| Z-0961-2021 | Class II | B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast med | January 4, 2021 |
| Z-1062-2021 | Class II | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage | January 4, 2021 |
| Z-0992-2021 | Class II | SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes | January 4, 2021 |
| Z-0991-2021 | Class II | SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes | January 4, 2021 |
| Z-1007-2021 | Class II | INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to per | January 4, 2021 |
| Z-1059-2021 | Class II | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ult | January 4, 2021 |
| Z-0964-2021 | Class II | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for inj | January 4, 2021 |
| Z-0993-2021 | Class II | INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes t | January 4, 2021 |
| Z-1002-2021 | Class II | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to per | January 4, 2021 |
| Z-1040-2021 | Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform | January 4, 2021 |
| Z-0978-2021 | Class II | KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electro | January 4, 2021 |
| Z-0980-2021 | Class II | KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosu | January 4, 2021 |
| Z-1056-2021 | Class II | NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to coll | January 4, 2021 |
| Z-1015-2021 | Class II | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes t | January 4, 2021 |
| Z-1026-2021 | Class II | INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to | January 4, 2021 |
| Z-1020-2021 | Class II | INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes t | January 4, 2021 |
| Z-1069-2021 | Class II | NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultraso | January 4, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K042160 | SONOSURG TROCAR | January 25, 2005 |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | September 8, 2004 |
| K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B | November 14, 2003 |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | October 1, 2003 |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | August 29, 2003 |
| K021672 | PANCREATIC DRAINAGE TUBE | April 16, 2003 |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | March 28, 2003 |