SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
FDA 510(k) clearance K000397 · decided 2000-03-07
Clearance details
- K-number
- K000397
- Device name
- SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2000-02-07
- Decision date
- 2000-03-07
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Multi-Band Ligator (K213223) | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| Ligation Device (K172985) | Leo Medical Co., Ltd. | 2018-06-14 |
| Wi-3 HAL-RAR System (K150718) | Agency For Medical Innovations GmbH | 2015-06-12 |
| NEXUS HEMORRHOID LIGATOR (K131282) | Inx Medical | 2013-07-11 |
| THD BANDY (K093497) | Thd Spa | 2010-07-15 |
| HAEMOBAND MULTI-LIGATOR (K091519) | Haemoband Surgical, Ltd. | 2009-07-28 |
| LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (K070881) | Sapimed S.P.A. | 2007-09-26 |
| SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 (K020824) | Boston Scientific Corp | 2002-04-12 |
| MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (K020526) | Don Wilson/Wilson-Cook Medical, Inc. | 2002-03-19 |
| RIZA BAND STRETCHER (RBS)-60000 (K001236) | R-Med, Inc. | 2000-07-17 |
| ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER (K000297) | Erchinger Medizintecnik | 2000-04-24 |
| SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR (K981669) | Boston Scientific Corp | 1998-06-04 |
Recalls involving this device
No recalls on record reference this clearance.