510(k) K200021
- Device
- Applied Medical Anoscope
- Applicant
- Applied Medical Resources
- 510(k) number
- K200021
- Product code
- FER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-06
- Date received
- 2020-01-06
- Regulation
- 876.1500
- Classification name
- Anoscope And Accessories
- 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
- Frans VandenBroek
- Address
- 22872 Avenida Empresa Rancho Santa CA US 92688 92688
FDA Registration Numbers#
- 9680091
- 3007789561
- 3016678045
- 1219930
- 3007388124
- 3011412640
- 9610612
- 1923569
- 3030733800
- 3006554912
- 3003636207
- 3005580113
- 1216677
- 2916714
- 3001845648
- 3034608931
- 3030447506
- 1316463
- 3013298431
- 3030446844
- 3006680097
- 1000379039
- 3010419931
- 3009328501
- 3015276780
- 3014579161
- 3010405378
- 3009380063
- 2027111
- 3007135420
- 3018094310
- 2032098
- 3022555975
- 1315756
- 3009051888
- 3012494290
- 3021917553
- 3012421607
- 3009763019
- 3013557562
- 9610621
- 3006787036
- 3004443374
- 3009526575
- 9680143
- 3003965134
- 3003139373
Source Documents#
Other 510(k) Records For Product Code FER #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. | 2025-10-09 |
| K242668 | Gastro Concepts Air Assist | Gastro Concepts, LLC | 2024-12-13 |
| K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 |
| K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017-07-20 |
| K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | Applied Medical Resources Corp. | 2014-01-02 |
| K133687 | THD N-ANO ANOSCOPE | Thd Spa | 2013-12-11 |
| K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | Obp Corporation | 2012-07-27 |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | Thd Spa | 2012-06-01 |
| K110792 | GELPOINT PATH | Applied Medical Resources Corp. | 2011-05-23 |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | Thd Spa | 2011-03-01 |
| K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | Ethicon Endo-Surgery, Inc. | 2010-03-25 |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Thd Spa | 2009-06-11 |
| K090432 | HEMORPEX SYSTEM | Angiologica B. M. Srl | 2009-05-29 |
| K080132 | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE | Thd Spa | 2008-04-09 |
| K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE | Sapimed S.P.A. | 2007-08-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases