Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
Summary
Iq Endoscopes Limited received 510(k) clearance for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100), a FDS device. Cleared on 2023-11-17.
Details
Source
510(k) Clearance
External ID
K232028
Action Date
2023-11-17
Status
Traditional
Category
device
Product Code
FDS
Product Description
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100). Product code: FDS.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Iq Endoscopes Limited have FDA actions?
This is the only FDA action we have on record for Iq Endoscopes Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232028" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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