Decision Date2023-03-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HOPKINS Telescopes is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K223923. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HOPKINS Telescopes?
HOPKINS Telescopes is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K223923.
When did HOPKINS Telescopes receive FDA 510(k) clearance?
HOPKINS Telescopes received FDA 510(k) clearance on 2023-03-30, under 510(k) number K223923.
Who is the listed applicant for HOPKINS Telescopes?
The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HOPKINS Telescopes?
The FDA product code for HOPKINS Telescopes is GCJ.
Other records listing KARL STORZ Endoscopy-America, 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.
PMA P050027Light source system, diagnostic endoscopicK252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System View all 52 devices →
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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.