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FDA 510(k)

KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM

K-Number: K122096 · 2012-09-27

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2012-09-27
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KARL STORZ NAVIGATIONPANEL UNIT (NPU) 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 2012-09-27 under 510(k) number K122096. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM?

KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-27. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K122096.

When did KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM receive FDA 510(k) clearance?

KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM received FDA 510(k) clearance on 2012-09-27, under 510(k) number K122096.

Who is the listed applicant for KARL STORZ NAVIGATIONPANEL UNIT (NPU) 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 NAVIGATIONPANEL UNIT (NPU) SYSTEM?

The FDA product code for KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM is HAW.

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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: HAW)

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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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