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FDA 510(k)

KARL STORZ NAV1 Electromagnetic Navigation System

K-Number: K161555 · 2016-10-21

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2016-10-21
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KARL STORZ NAV1 Electromagnetic Navigation 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 2016-10-21 under 510(k) number K161555. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ NAV1 Electromagnetic Navigation System?

KARL STORZ NAV1 Electromagnetic Navigation System is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K161555.

When did KARL STORZ NAV1 Electromagnetic Navigation System receive FDA 510(k) clearance?

KARL STORZ NAV1 Electromagnetic Navigation System received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161555.

Who is the listed applicant for KARL STORZ NAV1 Electromagnetic Navigation 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 KARL STORZ NAV1 Electromagnetic Navigation System?

The FDA product code for KARL STORZ NAV1 Electromagnetic Navigation System is PGW.

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: PGW)

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.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, 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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