Anoscope And Accessories
FDA product code FER · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To examine and perform procedures within the anus and rectum.
27510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Thd Spa 5
- Applied Medical Resources Corp 4
- Sightline Technologies , Ltd. 2
- Welch Allyn, Inc. 2
- Sapimed S.P.A. 1
- Haemoband Surgical, Ltd. 1
- Gastro Concepts, LLC 1
- Well Care (Wuhan) Medical Technology Co., Ltd. 1
- Obp Corporation 1
- Ethicon Endo-Surgery, Inc. 1
- Angiologica B. M. Srl 1
- Cook Ireland, Ltd. 1
- Canadian Theatre Products , Ltd. 1
- Dispos-A-Scope 1
- Inman Medical Corp. 1
- Baxter Healthcare Corp 1
- Galenica Enterprises, Inc. 1
- Exitec, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)FER · Traditional | Haemoband Surgical, Ltd. | 10/09/2025SE |
| K242668 | Gastro Concepts Air AssistFER · Traditional | Gastro Concepts, LLC | 12/13/2024SE |
| K230439 | WellCare AnoscopeFER · Traditional | Well Care (Wuhan) Medical Technology Co., Ltd. | 12/22/2023SE |
| K200021 | Applied Medical AnoscopeFER · Traditional | Applied Medical Resources | 01/06/2021SE |
| K171701 | GelPOINT Path Transanal Access PlatformFER · Traditional | Applied Medical Resources Corp. | 07/20/2017SE |
| K133393 | Gelpoint Path Transanal Access PlatformFER · Traditional | Applied Medical Resources Corp. | 01/02/2014SE |
| K133687 | THD N-Ano AnoscopeFER · Special | Thd Spa | 12/11/2013SE |
| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | Obp Corporation | 07/27/2012SE |
| K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeFER · Traditional | Thd Spa | 06/01/2012SE |
| K110792 | Gelpoint PathFER · Traditional | Applied Medical Resources Corp. | 05/23/2011SE |
| K103647 | THD Disposable Anoscopes, Proctoscopes and RectoscopesFER · Special | Thd Spa | 03/01/2011SE |
| K093896 | Ethicon Endo Surgery Slotted AnoscopeFER · Traditional | Ethicon Endo-Surgery, Inc. | 03/25/2010SE |
| K091490 | Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesFER · Special | Thd Spa | 06/11/2009SE |
| K090432 | Hemorpex SystemFER · Traditional | Angiologica B. M. Srl | 05/29/2009SE |
| K080132 | THD Disposable Anoscope/ProctoscopeFER · Traditional | Thd Spa | 04/09/2008SE |
| K070913 | Self-Light Disposable AnoscopeFER · Traditional | Sapimed S.P.A. | 08/10/2007SE |
| K060623 | Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview AnoscopeFER · Traditional | Cook Ireland, Ltd. | 09/06/2006SE |
| K020702 | O'Regan Disposable AnoscopeFER · Traditional | Canadian Theatre Products , Ltd. | 03/29/2002SE |
| K011825 | Rectosight RS300-04;AND Protosight PS300-04 DeviceFER · Special | Sightline Technologies , Ltd. | 07/11/2001SE |
| K994130 | Rectosight RS 300-04FER · Traditional | Sightline Technologies , Ltd. | 06/30/2000SE |
| K993738 | Dispos-A-ScopeFER · Traditional | Dispos-A-Scope | 01/06/2000SE |
| K921291 | Inman Medical Packing StripFER · Traditional | Inman Medical Corp. | 01/21/1993SE |
| K881469 | Angioscope W/Integrated Irrigating ChannelFER · Traditional | Baxter Healthcare Corp | 09/12/1988SE |
| K861017 | Galenica's Disposable AnoscopesFER · Traditional | Galenica Enterprises, Inc. | 06/13/1986SE |
| K822085 | Pro-ScopeFER · Traditional | Exitec, Inc. | 05/09/1983SE |
| K810227 | Model #53110 Disposable AnoscopeFER · Traditional | Welch Allyn, Inc. | 02/19/1981SE |
| K770906 | Anoscope, Optic, FiberFER · Traditional | Welch Allyn, Inc. | 06/01/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0510-2020 Class II | GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke…Unintentional shifting of the tip insulation of the firm's electrosurgical probes. | Applied Medical Resources Corp | 12/12/2018Terminated |