FDA 510(k)

LIMITED REUSE ENDOSCOPIC BLADES

K-Number: K971676 · 1997-06-27

Decision Date1997-06-27

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LIMITED REUSE ENDOSCOPIC BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971676. 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 LIMITED REUSE ENDOSCOPIC BLADES?

LIMITED REUSE ENDOSCOPIC BLADES is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K971676.

When did LIMITED REUSE ENDOSCOPIC BLADES receive FDA 510(k) clearance?

LIMITED REUSE ENDOSCOPIC BLADES received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971676.

Who is the listed applicant for LIMITED REUSE ENDOSCOPIC BLADES?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIMITED REUSE ENDOSCOPIC BLADES?

The FDA product code for LIMITED REUSE ENDOSCOPIC BLADES is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.