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FDA 510(k)

KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH

K-Number: K935277 · 1994-09-16

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1994-09-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH 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 1994-09-16 under 510(k) number K935277. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH?

KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K935277.

When did KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH receive FDA 510(k) clearance?

KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH received FDA 510(k) clearance on 1994-09-16, under 510(k) number K935277.

Who is the listed applicant for KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH?

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 HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH?

The FDA product code for KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH is GCJ.

Related Clinical Trials

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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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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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