PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
FDA 510(k) K232860 · Pentax of America, Inc.
Submission
- Device name
- PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- Applicant
- Pentax of America, Inc.
Montvale, NJ, US - Received
- September 15, 2023
- Decision date
- January 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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More from Intuitive Surgical, Inc.
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|---|---|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | 12/16/2025SE |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c)PEA · Traditional | 06/03/2025SE |
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| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | 08/01/2024SE |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH · Traditional | 07/24/2024SE |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…EOQ · Traditional | 01/12/2024SE |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14ODC · Traditional | 12/01/2023SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | 07/28/2023SE |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemEOQ · Traditional | 12/21/2022SE |
Questions and answers
When was PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U cleared by the FDA?
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K232860) received a 510(k) decision of Substantially Equivalent on January 18, 2024, 125 days after the submission was received.
What is the product code of K232860?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.