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FDA 510(k)

TIPCAM 1S 3D System

K-Number: K162410 · 2017-03-02

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2017-03-02
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TIPCAM 1S 3D System 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 K162410. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIPCAM 1S 3D System?

TIPCAM 1S 3D System 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 K162410.

When did TIPCAM 1S 3D System receive FDA 510(k) clearance?

TIPCAM 1S 3D System received FDA 510(k) clearance on 2017-03-02, under 510(k) number K162410.

Who is the listed applicant for TIPCAM 1S 3D System?

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 TIPCAM 1S 3D System?

The FDA product code for TIPCAM 1S 3D System is EOB.

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: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.

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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