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FDA 510(k)

ENDOFLATOR 40, ENDOFLATOR 50

K-Number: K161554 · 2017-03-02

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2017-03-02
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOFLATOR 40, ENDOFLATOR 50 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 2017-03-02 under 510(k) number K161554. 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 ENDOFLATOR 40, ENDOFLATOR 50?

ENDOFLATOR 40, ENDOFLATOR 50 is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K161554.

When did ENDOFLATOR 40, ENDOFLATOR 50 receive FDA 510(k) clearance?

ENDOFLATOR 40, ENDOFLATOR 50 received FDA 510(k) clearance on 2017-03-02, under 510(k) number K161554.

Who is the listed applicant for ENDOFLATOR 40, ENDOFLATOR 50?

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 ENDOFLATOR 40, ENDOFLATOR 50?

The FDA product code for ENDOFLATOR 40, ENDOFLATOR 50 is HIF.

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: 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.

K252584Insufflator (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 CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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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