FDA 510(k)

KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY

K-Number: K970055 · 1997-03-05

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1997-03-05

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY 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 1997-03-05 under 510(k) number K970055. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY?

KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY is a medical device that received FDA 510(k) clearance on 1997-03-05. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K970055.

When did KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY receive FDA 510(k) clearance?

KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY received FDA 510(k) clearance on 1997-03-05, under 510(k) number K970055.

Who is the listed applicant for KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY?

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 MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY?

The FDA product code for KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY is HRX.

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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.