HOPKINS Telescopes
Summary
Karl Storz Endoscopy America, Inc. received 510(k) clearance for HOPKINS Telescopes, a HIH device. Cleared on 2023-09-14.
Details
Source
510(k) Clearance
External ID
K223885
Action Date
2023-09-14
Status
Traditional
Category
device
Product Code
HIH
Product Description
HOPKINS Telescopes. Product code: HIH.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 device clearances issued this month. Karl Storz Endoscopy America, Inc. has received 12 total clearances in our database.
Karl Storz Endoscopy America, Inc. has 12 FDA actions in our database, including 12 clearances.
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 Karl Storz Endoscopy America, Inc. have FDA actions?
Karl Storz Endoscopy America, Inc. has 12 FDA actions in our database, including 0 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223885" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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