510(k) K020824
- Device
- SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K020824
- Product code
- FHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-12
- Date received
- 2002-03-14
- Regulation
- 876.4400
- Classification name
- Ligator, Hemorrhoidal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHLEEN MORAHAN
- Address
- One Boston Scientific Pl. Natick, MA US 01760 01760
FDA Registration Numbers#
- 3023657851
- 9611112
- 3010138349
- 3004215117
- 2431166
- 3004443374
- 3005580113
- 3017103427
- 1421879
- 3003902757
- 3004837686
- 3010041511
- 3042854900
- 3005049530
- 3010687973
- 9615917
- 9611827
- 3008338766
- 1315756
- 3004598675
- 3015895045
- 3008274780
- 3027556548
- 3001620590
- 3009526575
- 3004784004
- 3003965134
- 3013440400
- 3004001706
- 1836161
- 1223925
- 3012042439
- 3043226252
- 3007388124
- 3016678045
- 2529846
- 3007695959
- 2027062
- 1528319
- 3003418325
- 3013681539
- 3030733800
- 2126670
- 3001845648
- 3011137372
- 3007137643
- 1417592
- 9617744
- 3014579161
- 3005987240
- 3011499367
- 8022032
- 1424478
- 2916714
- 3007305485
- 1123010
- 3014174994
- 3012833053
- 2032677
- 3008797804
- 3014620201
- 3001644167
- 3007648354
- 3011347300
- 3029995792
- 9610612
- 2183570
- 3022555975
- 2084346
- 3011412640
- 3005809810
- 3006554912
- 3016069968
- 1320894
- 3005099803
- 3008770252
- 3006680097
- 3030446844
- 3011570296
- 3010011359
Source Documents#
Other 510(k) Records For Product Code FHN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | 2018-06-14 |
| K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015-06-12 |
| K131282 | NEXUS HEMORRHOID LIGATOR | Inx Medical | 2013-07-11 |
| K093497 | THD BANDY | Thd Spa | 2010-07-15 |
| K091519 | HAEMOBAND MULTI-LIGATOR | Haemoband Surgical, Ltd. | 2009-07-28 |
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | 2007-09-26 |
| K020526 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | Don Wilson/Wilson-Cook Medical, Inc. | 2002-03-19 |
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | 2000-07-17 |
| K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | Erchinger Medizintecnik | 2000-04-24 |
| K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | Boston Scientific Corp | 2000-03-07 |
| K981669 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1998-06-04 |
| K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | Wilson-Cook Medical, Inc. | 1998-01-20 |
| K963166 | O'REGAN LIGATOR | Patrick J. O'Regan | 1997-05-05 |
| K964079 | SPEEDBAND MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1997-02-13 |
Legacy Summary#
summary
FDA Review#
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