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FDA 510(k)

KARL STORZ BOUGIES, SOUNDS, DILATORS

K-Number: K946331 · 1995-03-02

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1995-03-02
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KARL STORZ BOUGIES, SOUNDS, DILATORS 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 1995-03-02 under 510(k) number K946331. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ BOUGIES, SOUNDS, DILATORS?

KARL STORZ BOUGIES, SOUNDS, DILATORS is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K946331.

When did KARL STORZ BOUGIES, SOUNDS, DILATORS receive FDA 510(k) clearance?

KARL STORZ BOUGIES, SOUNDS, DILATORS received FDA 510(k) clearance on 1995-03-02, under 510(k) number K946331.

Who is the listed applicant for KARL STORZ BOUGIES, SOUNDS, DILATORS?

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 BOUGIES, SOUNDS, DILATORS?

The FDA product code for KARL STORZ BOUGIES, SOUNDS, DILATORS is EOX.

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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: EOX)

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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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