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FDA 510(k)

IMAGE1 SPIES

K-Number: K131953 · 2013-12-20

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2013-12-20
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMAGE1 SPIES 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 2013-12-20 under 510(k) number K131953. 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 SPIES?

IMAGE1 SPIES is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K131953.

When did IMAGE1 SPIES receive FDA 510(k) clearance?

IMAGE1 SPIES received FDA 510(k) clearance on 2013-12-20, under 510(k) number K131953.

Who is the listed applicant for IMAGE1 SPIES?

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 SPIES?

The FDA product code for IMAGE1 SPIES is FET.

Related Clinical Trials

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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.

K252624KARL 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 SystemK223923HOPKINS Telescopes

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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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.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.

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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