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FDA 510(k)

KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR

K-Number: K946330 · 1995-02-06

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1995-02-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR 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 1995-02-06 under 510(k) number K946330. 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 STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR?

KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR is a medical device that received FDA 510(k) clearance on 1995-02-06. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K946330.

When did KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR receive FDA 510(k) clearance?

KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR received FDA 510(k) clearance on 1995-02-06, under 510(k) number K946330.

Who is the listed applicant for KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR?

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 STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR?

The FDA product code for KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR 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.

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