Product code FER
- Device name
- Anoscope And Accessories
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To examine and perform procedures within the anus and rectum.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K200021 | Applied Medical Anoscope | Applied Medical Resources | 2021-01-06 |
| 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 |
| K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | Cook Ireland, Ltd. | 2006-09-06 |
| K020702 | O'REGAN DISPOSABLE ANOSCOPE | Canadian Theatre Products , Ltd. | 2002-03-29 |
| K011825 | RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE | Sightline Technologies , Ltd. | 2001-07-11 |
| K994130 | RECTOSIGHT RS 300-04 | Sightline Technologies , Ltd. | 2000-06-30 |
| K993738 | DISPOS-A-SCOPE | Dispos-A-Scope | 2000-01-06 |
| K921291 | INMAN MEDICAL PACKING STRIP | Inman Medical Corp. | 1993-01-21 |
| K881469 | ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL | Baxter Healthcare Corp | 1988-09-12 |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | Galenica Enterprises, Inc. | 1986-06-13 |
| K822085 | PRO-SCOPE | Exitec, Inc. | 1983-05-09 |
| K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | Welch Allyn, Inc. | 1981-02-19 |
| K770906 | ANOSCOPE, OPTIC, FIBER | Welch Allyn, Inc. | 1977-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033638802861 | Self-light anoscopes | SAPI MED SPA | 2026-02-06 |
| 08033638802885 | Self-light anoscopes | SAPI MED SPA | 2023-07-27 |
| 08033638800430 | Self-light anoscopes | SAPI MED SPA | 2023-07-27 |
| 08033638800478 | Self-light anoscopes | SAPI MED SPA | 2023-07-27 |
| 08033638800485 | Self-light anoscopes | SAPI MED SPA | 2023-07-27 |
| 08033638801352 | Epoflier | SAPI MED SPA | 2023-07-27 |
| 08033737710074 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710036 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710081 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710098 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710104 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710111 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710128 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710135 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710142 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710159 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710166 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710173 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710067 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710050 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710043 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710029 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710012 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033638800140 | Retractor | SAPI MED SPA | 2016-11-30 |
| 08033638800027 | Anoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800126 | Retractor | SAPI MED SPA | 2016-11-25 |
| 08033638800102 | Retractor | SAPI MED SPA | 2016-11-25 |
| 08033638800089 | Retractor | SAPI MED SPA | 2016-11-25 |
| 08033638800065 | Anoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800041 | Anoscope | SAPI MED SPA | 2016-11-25 |