Product code LQC
- Device name
- Lithotriptor, Biliary Mechanical
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040447 | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 | Boston Scientific Corp | 2004-03-12 |
| K011178 | WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR | Wilson-Cook Medical, Inc. | 2001-05-04 |
| K964937 | A LITHOTRIPTER-COMPATIBLE BASKET | Boston Scientific Corp | 1997-01-24 |
| K942544 | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS | Medi-Globe Corp. | 1994-11-22 |
| K943191 | MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR | Boston Scientific Corp | 1994-08-29 |
| K905552 | LAPAROLITH | Baxter Healthcare Corp | 1991-12-17 |
| K911364 | SPOON FORCEPS, 11MM | Northgate Technologies, Inc. | 1991-10-23 |
| K911477 | LAPAROSCOPIC BASKET FLEXIBLE AND RIGID | United States Endoscopy Group, Inc. | 1991-08-14 |
| K903529 | BML SERIES | Olympus Corp. | 1991-01-23 |
| K902170 | SOEHENDRA LITHOTRIPSY SET | Wilson-Cook Medical, Inc. | 1990-07-25 |
| K860863 | ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER | George Percy Mcgown | 1986-05-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810143890921 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2024-04-15 |
| 04953170462610 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2024-03-25 |
| 04953170462597 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2024-03-25 |
| 14953170462594 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2024-03-25 |
| 14953170462617 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2024-03-25 |
| 14953170433655 | Single Use BML Handle V | OLYMPUS MEDICAL SYSTEMS CORP. | 2022-09-16 |
| 04953170433658 | Single Use BML Handle V | OLYMPUS MEDICAL SYSTEMS CORP. | 2022-09-16 |
| 00850033250671 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-08-12 |
| 00850033250664 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-08-12 |
| 14953170420297 | Single Use Mechanical Lithotriptor BML-610A | OLYMPUS MEDICAL SYSTEMS CORP. | 2021-12-17 |
| 04953170420290 | Single Use Mechanical Lithotriptor BML-610A | OLYMPUS MEDICAL SYSTEMS CORP. | 2021-12-17 |
| 00827002572836 | COOK | COOK INCORPORATED | 2021-05-05 |
| 04953170420283 | OLYMPUS | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-12-10 |
| 08714729296379 | Trapezoid RX | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729296386 | Trapezoid RX | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729296393 | Trapezoid RX | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729296409 | Trapezoid RX | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 00827002216044 | Soehendra | COOK INCORPORATED | 2016-09-24 |
| 04048551079478 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04953170218422 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170218415 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170218392 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170218385 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170218361 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170218347 | Single Use Mechanical Lithotriptor V | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170033070 | DISPOSABLE MECHANICAL LITHOTRIPTOR | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170032981 | Basket Wire | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170032875 | Basket Wire | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170032769 | Basket Wire | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170032745 | Basket Wire | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |