Decision Date2004-03-09
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SOHNIKS is the device name listed in this FDA 510(k) record. The listed applicant is Sohniks Endoscopy, Inc.. It received FDA 510(k) clearance on 2004-03-09 under 510(k) number K033191. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SOHNIKS?
SOHNIKS is a medical device that received FDA 510(k) clearance on 2004-03-09. The listed applicant is Sohniks Endoscopy, Inc.. The 510(k) number is K033191.
When did SOHNIKS receive FDA 510(k) clearance?
SOHNIKS received FDA 510(k) clearance on 2004-03-09, under 510(k) number K033191.
Who is the listed applicant for SOHNIKS?
The FDA 510(k) record lists Sohniks Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SOHNIKS?
The FDA product code for SOHNIKS is FAJ.
Related Clinical Trials
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Other records listing Sohniks Endoscopy, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FAJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.