UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205
Summary
Karl Storz SE & CO. KG received 510(k) clearance for UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10), a HIH device. Cleared on 2026-09-25.
Details
Source
510(k) Clearance
External ID
K254252
Action Date
2026-09-25
Status
Traditional
Category
device
Product Code
HIH
Product Description
UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10). Product code: HIH.
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 518 device clearances issued this month. Karl Storz SE & CO. KG has received 29 total clearances in our database.
Karl Storz SE & CO. KG has 29 FDA actions in our database, including 29 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 SE & CO. KG have FDA actions?
Karl Storz SE & CO. KG has 29 FDA actions in our database, including 0 recalls and 29 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254252" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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