Galenica's Disposable Anoscopes

Q: What is the product code of K861017?

The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.

FDA 510(k) K861017 · Galenica Enterprises, Inc.

Substantially Equivalent

510(k) numberK861017

Submission

Device name: Galenica's Disposable Anoscopes
Applicant: Galenica Enterprises, Inc.
Quebec Canada J7e 4h7, CA
Received: March 18, 1986
Decision date: June 13, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: FER – Anoscope And Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Specialty: Gastroenterology, Urology

To examine and perform procedures within the anus and rectum.

Other 510(k)s with product code FER

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

More from Applied Medical Resources Corp.

510(k)	Device	Decision
K923656	Lighting Source SystemHIC · Traditional	09/08/1994SE
K896383	Disposable External ClampsGDI · Traditional	12/06/1989SE
K883283	Disposable AmniotomeHGG · Traditional	10/18/1988SE
K841909	Vaginal Speculum - DisposableHIB · Traditional	07/31/1984SE

Questions and answers

When was Galenica's Disposable Anoscopes cleared by the FDA?

Galenica's Disposable Anoscopes (K861017) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 87 days after the submission was received.

What is the product code of K861017?

The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.