Panels › Gastroenterology, Urology › Product code FER · Class 2
Anoscope And Accessories
Regulation 876.1500
0510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FER
| Company | 510(k)s | Recalls |
|---|---|---|
| Applied Medical Resources | 4 | 1 |
| Thd Spa | 5 | 0 |
| Sightline Technologies , Ltd. | 2 | 0 |
| Welch Allyn, Inc. | 2 | 0 |
| Angiologica B. M. Srl | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Canadian Theatre Products , Ltd. | 1 | 0 |
| Cook Ireland, Ltd. | 1 | 0 |
| Dispos-A-Scope | 1 | 0 |
| Ethicon Endo-Surgery, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2025 | K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) Haemoband Surgical, Ltd., GB | FER |
| Dec 13, 2024 | K242668 | Gastro Concepts Air Assist Gastro Concepts, LLC | FER |
| Dec 22, 2023 | K230439 | WellCare Anoscope Well Care (Wuhan) Medical Technology Co., Ltd., CN | FER |
| Jan 6, 2021 | K200021 | Applied Medical Anoscope Applied Medical Resources | FER |
| Jul 20, 2017 | K171701 | GelPOINT Path Transanal Access Platform Applied Medical Resources Corp. | FER |
| Jan 2, 2014 | K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM Applied Medical Resources Corp. | FER |
| Dec 11, 2013 | K133687 | THD N-ANO ANOSCOPE Thd Spa, IT | FER |
| Jul 27, 2012 | K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT Obp Corporation | FER |
| Jun 1, 2012 | K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE Thd Spa, IT | FER |
| May 23, 2011 | K110792 | GELPOINT PATH Applied Medical Resources Corp. | FER |
| Mar 1, 2011 | K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES Thd Spa, IT | FER |
| Mar 25, 2010 | K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE Ethicon Endo-Surgery, Inc. | FER |
| Jun 11, 2009 | K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES Thd Spa, IT | FER |
| May 29, 2009 | K090432 | HEMORPEX SYSTEM Angiologica B. M. Srl, IT | FER |
| Apr 9, 2008 | K080132 | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE Thd Spa, IT | FER |
| Aug 10, 2007 | K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE Sapimed S.P.A. | FER |
| Sep 6, 2006 | K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE Cook Ireland, Ltd., IE | FER |
| Mar 29, 2002 | K020702 | O'REGAN DISPOSABLE ANOSCOPE Canadian Theatre Products , Ltd., CA | FER |
| Jul 11, 2001 | K011825 | RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE Sightline Technologies , Ltd., IL | FER |
| Jun 30, 2000 | K994130 | RECTOSIGHT RS 300-04 Sightline Technologies , Ltd., IL | FER |
| Jan 6, 2000 | K993738 | DISPOS-A-SCOPE Dispos-A-Scope | FER |
| Jan 21, 1993 | K921291 | INMAN MEDICAL PACKING STRIP Inman Medical Corp. | FER |
| Sep 12, 1988 | K881469 | ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL Baxter Healthcare Corp | FER |
| Jun 13, 1986 | K861017 | GALENICA'S DISPOSABLE ANOSCOPES Galenica Enterprises, Inc., CA | FER |
| May 9, 1983 | K822085 | PRO-SCOPE Exitec, Inc. | FER |
| Feb 19, 1981 | K810227 | MODEL #53110 DISPOSABLE ANOSCOPE Welch Allyn, Inc. | FER |
| Jun 1, 1977 | K770906 | ANOSCOPE, OPTIC, FIBER Welch Allyn, Inc. | FER |
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