SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
FDA 510(k) clearance K060623 · decided 2006-09-06
Clearance details
- K-number
- K060623
- Device name
- SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
- Applicant
- Cook Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-08
- Decision date
- 2006-09-06
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- FER
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Limerick, IE
- Third-party review
- No
- Expedited review
- No
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| WellCare Anoscope (K230439) | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 |
| Applied Medical Anoscope (K200021) | Applied Medical Resources | 2021-01-06 |
| GelPOINT Path Transanal Access Platform (K171701) | Applied Medical Resources Corp. | 2017-07-20 |
| GELPOINT PATH TRANSANAL ACCESS PLATFORM (K133393) | Applied Medical Resources Corp. | 2014-01-02 |
| THD N-ANO ANOSCOPE (K133687) | Thd Spa | 2013-12-11 |
| ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (K121604) | Obp Corporation | 2012-07-27 |
| THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (K121135) | Thd Spa | 2012-06-01 |
| GELPOINT PATH (K110792) | Applied Medical Resources Corp. | 2011-05-23 |
| THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (K103647) | Thd Spa | 2011-03-01 |
| ETHICON ENDO SURGERY SLOTTED ANOSCOPE (K093896) | Ethicon Endo-Surgery, Inc. | 2010-03-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zilver Flex® 35 Vascular Stent (P050017/S025) | Cook Ireland, Ltd. | 2025-10-22 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| Zilver Flex(R) 35 Vascular Stent (P050017/S024) | Cook Ireland, Ltd. | 2025-07-01 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Zilver® PTX® Peripheral Drug- Eluting Stent (P100022/S042) | Cook Ireland, Ltd. | 2023-09-22 |