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FDA 510(k)

Applied Medical Anoscope

K-Number: K200021 · 2021-01-06

ApplicantApplied Medical Resources
Decision Date2021-01-06
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Applied Medical Anoscope is a medical device manufactured by Applied Medical Resources. It received FDA 510(k) clearance on 2021-01-06 under approval number K200021. 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 Applied Medical Anoscope?

Applied Medical Anoscope is a medical device that received FDA 510(k) clearance on 2021-01-06. It is manufactured by Applied Medical Resources. The 510(k) number is K200021.

When was Applied Medical Anoscope approved by the FDA?

Applied Medical Anoscope received FDA 510(k) clearance on 2021-01-06, under approval number K200021.

What company makes Applied Medical Anoscope?

Applied Medical Anoscope is manufactured by Applied Medical Resources.

What is the FDA product code for Applied Medical Anoscope?

The FDA product code for Applied Medical Anoscope is FER.

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Related PubMed Literature

PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026) PMID: 41832928 Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China. European radiology (2026) PMID: 40985063 Risk Identification and Regulation for China's Anti-Commercial Bribery in Medical Device Procurement and Sales Industry. Chinese medical sciences journal = Chung-kuo i hsueh k'o hsueh tsa chih (2025) PMID: 40969652 Risk-sharing agreements for medical devices: a stakeholder-based qualitative study in Czechia. Frontiers in public health (2025)

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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.

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