Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE

K-Number: K011825 · 2001-07-11

ApplicantSightline Technologies , Ltd.
Decision Date2001-07-11
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sightline Technologies , Ltd.. It received FDA 510(k) clearance on 2001-07-11 under 510(k) number K011825. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE?

RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE is a medical device that received FDA 510(k) clearance on 2001-07-11. The listed applicant is Sightline Technologies , Ltd.. The 510(k) number is K011825.

When did RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE receive FDA 510(k) clearance?

RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE received FDA 510(k) clearance on 2001-07-11, under 510(k) number K011825.

Who is the listed applicant for RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE?

The FDA 510(k) record lists Sightline Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE?

The FDA product code for RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE is FER.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sightline Technologies , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032688COLONOSIGHT MODEL 510BK994130RECTOSIGHT RS 300-04

Related Devices (Code: FER)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.K242668Gastro Concepts Air AssistGastro Concepts, LLCK230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.K133687THD N-ANO ANOSCOPEThd Spa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑