Sentient Manufacturing Laser Fiber
K-Number: K213554 · 2022-02-02
ApplicantSentient Manufacturing , LLC
Decision Date2022-02-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sentient Manufacturing Laser Fiber is a medical device manufactured by Sentient Manufacturing , LLC. It received FDA 510(k) clearance on 2022-02-02 under approval number K213554. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sentient Manufacturing Laser Fiber?
Sentient Manufacturing Laser Fiber is a medical device that received FDA 510(k) clearance on 2022-02-02. It is manufactured by Sentient Manufacturing , LLC. The 510(k) number is K213554.
When was Sentient Manufacturing Laser Fiber approved by the FDA?
Sentient Manufacturing Laser Fiber received FDA 510(k) clearance on 2022-02-02, under approval number K213554.
What company makes Sentient Manufacturing Laser Fiber?
Sentient Manufacturing Laser Fiber is manufactured by Sentient Manufacturing , LLC.
What is the FDA product code for Sentient Manufacturing Laser Fiber?
The FDA product code for Sentient Manufacturing Laser Fiber is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.