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FDA 510(k)

Image1 S CCU, Image1 S 4U Camera Head

K-Number: K201135 · 2020-09-01

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2020-09-01
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Image1 S CCU, Image1 S 4U Camera Head 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 2020-09-01 under 510(k) number K201135. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image1 S CCU, Image1 S 4U Camera Head?

Image1 S CCU, Image1 S 4U Camera Head is a medical device that received FDA 510(k) clearance on 2020-09-01. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K201135.

When did Image1 S CCU, Image1 S 4U Camera Head receive FDA 510(k) clearance?

Image1 S CCU, Image1 S 4U Camera Head received FDA 510(k) clearance on 2020-09-01, under 510(k) number K201135.

Who is the listed applicant for Image1 S CCU, Image1 S 4U Camera Head?

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 Image1 S CCU, Image1 S 4U Camera Head?

The FDA product code for Image1 S CCU, Image1 S 4U Camera Head is FET.

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

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Related Devices (Code: FET)

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.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation

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.

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