Rectosight RS300-04;AND Protosight PS300-04 Device

Q: What is the product code of K011825?

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

FDA 510(k) K011825 · Sightline Technologies , Ltd.

Substantially Equivalent

510(k) numberK011825

Submission

Device name: Rectosight RS300-04;AND Protosight PS300-04 Device
Applicant: Sightline Technologies , Ltd.
Matam, Haifa, IL
Received: June 11, 2001
Decision date: July 11, 2001
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) statement available from FDA

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

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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
K032688	Colonosight Model 510BFDF · Traditional	03/05/2004SE
K994130	Rectosight RS 300-04FER · Traditional	06/30/2000SE

Questions and answers

When was Rectosight RS300-04;AND Protosight PS300-04 Device cleared by the FDA?

Rectosight RS300-04;AND Protosight PS300-04 Device (K011825) received a 510(k) decision of Substantially Equivalent on July 11, 2001, 30 days after the submission was received.

What is the product code of K011825?

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