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FDA 510(k)

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

K-Number: K232028 · 2023-11-17

ApplicantIq Endoscopes Limited
Decision Date2023-11-17
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is a medical device manufactured by Iq Endoscopes Limited. It received FDA 510(k) clearance on 2023-11-17 under approval number K232028. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Iq Endoscopes Limited. The 510(k) number is K232028.

When was Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) approved by the FDA?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) received FDA 510(k) clearance on 2023-11-17, under approval number K232028.

What company makes Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is manufactured by Iq Endoscopes Limited.

What is the FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

The FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is FDS.

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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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