FDA Product Code
FDA Product Code FER — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | Haemoband Surgical, Ltd. | 2025-10-09 | Traditional | PDF ↗ |
| K242668 | Gastro Concepts Air Assist | Gastro Concepts, LLC | 2024-12-13 | Traditional | PDF ↗ |
| K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K200021 | Applied Medical Anoscope | Applied Medical Resources | 2021-01-06 | Traditional | PDF ↗ |
| K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017-07-20 | Traditional | PDF ↗ |
| K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM | Applied Medical Resources Corp. | 2014-01-02 | Traditional | PDF ↗ |
| K133687 | THD N-ANO ANOSCOPE | Thd Spa | 2013-12-11 | Special | PDF ↗ |
| K121604 | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT | Obp Corporation | 2012-07-27 | Traditional | PDF ↗ |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | Thd Spa | 2012-06-01 | Traditional | PDF ↗ |
| K110792 | GELPOINT PATH | Applied Medical Resources Corp. | 2011-05-23 | Traditional | PDF ↗ |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | Thd Spa | 2011-03-01 | Special | PDF ↗ |
| K093896 | ETHICON ENDO SURGERY SLOTTED ANOSCOPE | Ethicon Endo-Surgery, Inc. | 2010-03-25 | Traditional | PDF ↗ |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Thd Spa | 2009-06-11 | Special | PDF ↗ |
| K090432 | HEMORPEX SYSTEM | Angiologica B. M. Srl | 2009-05-29 | Traditional | PDF ↗ |
| K080132 | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE | Thd Spa | 2008-04-09 | Traditional | PDF ↗ |
| K070913 | SELF-LIGHT DISPOSABLE ANOSCOPE | Sapimed S.P.A. | 2007-08-10 | Traditional | PDF ↗ |
| K060623 | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | Cook Ireland, Ltd. | 2006-09-06 | Traditional | PDF ↗ |
| K020702 | O'REGAN DISPOSABLE ANOSCOPE | Canadian Theatre Products , Ltd. | 2002-03-29 | Traditional | PDF ↗ |
| K011825 | RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE | Sightline Technologies , Ltd. | 2001-07-11 | Special | PDF ↗ |
| K994130 | RECTOSIGHT RS 300-04 | Sightline Technologies , Ltd. | 2000-06-30 | Traditional | PDF ↗ |
| K993738 | DISPOS-A-SCOPE | Dispos-A-Scope | 2000-01-06 | Traditional | PDF ↗ |
| K921291 | INMAN MEDICAL PACKING STRIP | Inman Medical Corp. | 1993-01-21 | Traditional | PDF ↗ |
| K881469 | ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL | Baxter Healthcare Corp | 1988-09-12 | Traditional | PDF ↗ |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | Galenica Enterprises, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K822085 | PRO-SCOPE | Exitec, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | Welch Allyn, Inc. | 1981-02-19 | Traditional | PDF ↗ |
| K770906 | ANOSCOPE, OPTIC, FIBER | Welch Allyn, Inc. | 1977-06-01 | Traditional | PDF ↗ |
Product code FER · Class II · Gastroenterology, Urology. Data: openFDA.