FDA 510(k)

TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES

K-Number: K940347 · 1994-06-02

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1994-06-02

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES 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 1994-06-02 under 510(k) number K940347. 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 TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES?

TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K940347.

When did TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES receive FDA 510(k) clearance?

TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940347.

Who is the listed applicant for TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES?

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 TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES?

The FDA product code for TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES is GCJ.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

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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.