FDA product code FER: Anoscope And Accessories
FER is the FDA product code for anoscope and accessories. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 27 510(k) submissions under FER, 3 in the last five years, from 19 different applicants. The average 510(k) review took 118 days (median 82); 159 days on average over the last three years. FDA has posted 1 recall for FER devices.
Definition
To examine and perform procedures within the anus and rectum.
Classification
| Field | Value |
|---|---|
| Device name | Anoscope And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FER
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 42 |
| 2021 | 1 | 366 |
| 2023 | 1 | 304 |
| 2024 | 1 | 99 |
| 2025 | 1 | 219 |
Compare with all 510(k) review times · Search every FER clearance
Top FER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thd Spa | 5 | 2013-12-11 |
| Applied Medical Resources Corp. | 3 | 2017-07-20 |
| Sightline Technologies , Ltd. | 2 | 2001-07-11 |
| Welch Allyn, Inc. | 2 | 1981-02-19 |
| Haemoband Surgical, Ltd. | 1 | 2025-10-09 |
14 more applicants have FER clearances. See the full list in Caduvo.
Most recent FER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250645 | Haemoband Surgical, Ltd. | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | 2025-10-09 | 219 |
| K242668 | Gastro Concepts, LLC | Gastro Concepts Air Assist | 2024-12-13 | 99 |
| K230439 | Well Care (Wuhan) Medical Technology Co., Ltd. | WellCare Anoscope | 2023-12-22 | 304 |
| K200021 | Applied Medical Resources | Applied Medical Anoscope | 2021-01-06 | 366 |
| K171701 | Applied Medical Resources Corp. | GelPOINT Path Transanal Access Platform | 2017-07-20 | 42 |
Recalls for FER devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code FER?
FER is the FDA product code for anoscope and accessories. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FER?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FER?
Across 27 cleared submissions the average was 118 days from receipt to decision (median 82).
Which companies have the most FER clearances?
Thd Spa (5); Applied Medical Resources Corp. (3); Sightline Technologies , Ltd. (2); Welch Allyn, Inc. (2); Haemoband Surgical, Ltd. (1).
Have FER devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code FER
- Run a recall and safety report across every FER manufacturer
- Watch product code FER for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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