GELPOINT PATH TRANSANAL ACCESS PLATFORM
FDA 510(k) clearance K133393 · decided 2014-01-02
Clearance details
- K-number
- K133393
- Device name
- GELPOINT PATH TRANSANAL ACCESS PLATFORM
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-05
- Decision date
- 2014-01-02
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- FER
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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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 |
| 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 |
| FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES (K091490) | Thd Spa | 2009-06-11 |
Recalls involving this device
No recalls on record reference this clearance.