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)

Andorate Universal Endoscope Tip Guard

K-Number: K202838 · 2021-03-05

ApplicantGa Health Company Limited
Decision Date2021-03-05
Product CodeOCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Andorate Universal Endoscope Tip Guard is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K202838. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Andorate Universal Endoscope Tip Guard?

Andorate Universal Endoscope Tip Guard is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Ga Health Company Limited. The 510(k) number is K202838.

When did Andorate Universal Endoscope Tip Guard receive FDA 510(k) clearance?

Andorate Universal Endoscope Tip Guard received FDA 510(k) clearance on 2021-03-05, under 510(k) number K202838.

Who is the listed applicant for Andorate Universal Endoscope Tip Guard?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Andorate Universal Endoscope Tip Guard?

The FDA product code for Andorate Universal Endoscope Tip Guard is OCU.

Other records listing Ga Health Company Limited 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.

K232118ANDORATE® Valve KitK231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingK230932ANDORATE® Valve KitK230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveK223171AquaPulse® Irrigation TubingK213095andorate Suction Valve, andorate Air/Water Valve

View all 12 devices →

Related Devices (Code: OCU)

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.

K191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileSTERIS CorporationK191011Scope ProTechMeditech Endoscopy, Ltd.

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.

↑