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FDA 510(k)

KSEA THERMOFLATOR (MODEL 26 4320 20)

K-Number: K955073 · 1996-12-06

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1996-12-06
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KSEA THERMOFLATOR (MODEL 26 4320 20) 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 1996-12-06 under 510(k) number K955073. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA THERMOFLATOR (MODEL 26 4320 20)?

KSEA THERMOFLATOR (MODEL 26 4320 20) is a medical device that received FDA 510(k) clearance on 1996-12-06. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K955073.

When did KSEA THERMOFLATOR (MODEL 26 4320 20) receive FDA 510(k) clearance?

KSEA THERMOFLATOR (MODEL 26 4320 20) received FDA 510(k) clearance on 1996-12-06, under 510(k) number K955073.

Who is the listed applicant for KSEA THERMOFLATOR (MODEL 26 4320 20)?

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 KSEA THERMOFLATOR (MODEL 26 4320 20)?

The FDA product code for KSEA THERMOFLATOR (MODEL 26 4320 20) is HIF.

Related Clinical Trials

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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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: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems 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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