510(k) K943191
- Device
- Microvasive(r) Monolith(tm) Mechanical Lithotriptor
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K943191
- Product code
- LQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-29
- Date received
- 1994-07-05
- Regulation
- 876.4500
- Classification name
- Lithotriptor, Biliary Mechanical
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE M HARRIS
- Address
- 480 Pleasant St. Watertown MA US 02472 02472
FDA Registration Numbers#
- 1037905
- 3030516433
- 8010047
- 3010202439
- 2020550
- 3021009035
- 9617744
- 9681260
- 9614641
- 3005099803
- 3005987240
- 3014615697
- 3011050570
- 1000393132
- 1828132
- 1000121056
- 3010273872
- 8010418
- 3010399422
- 3004361445
- 3014769442
- 9680718
Source Documents#
Other 510(k) Records For Product Code LQC#
| 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 |
| 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 |