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)

MODEL #53110 DISPOSABLE ANOSCOPE

K-Number: K810227 · 1981-02-19

ApplicantWelch Allyn, Inc.
Decision Date1981-02-19
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL #53110 DISPOSABLE ANOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 1981-02-19 under 510(k) number K810227. 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 MODEL #53110 DISPOSABLE ANOSCOPE?

MODEL #53110 DISPOSABLE ANOSCOPE is a medical device that received FDA 510(k) clearance on 1981-02-19. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K810227.

When did MODEL #53110 DISPOSABLE ANOSCOPE receive FDA 510(k) clearance?

MODEL #53110 DISPOSABLE ANOSCOPE received FDA 510(k) clearance on 1981-02-19, under 510(k) number K810227.

Who is the listed applicant for MODEL #53110 DISPOSABLE ANOSCOPE?

The FDA 510(k) record lists Welch Allyn, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL #53110 DISPOSABLE ANOSCOPE?

The FDA product code for MODEL #53110 DISPOSABLE ANOSCOPE 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 Welch Allyn, Inc. 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

View all 109 devices →

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.

↑