PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use,
Summary
Pentax of America, Inc. received 510(k) clearance for PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ), a FDT device. Cleared on 2024-08-01.
Details
Source
510(k) Clearance
External ID
K233942
Action Date
2024-08-01
Status
Traditional
Category
device
Product Code
FDT
Product Description
PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ). Product code: FDT.
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. Pentax of America, Inc. has received 16 total clearances in our database.
Pentax of America, Inc. has 22 FDA actions in our database, including 6 recalls and 16 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 Pentax of America, Inc. have FDA actions?
Pentax of America, Inc. has 22 FDA actions in our database, including 6 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233942" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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