FDA 510(k)

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

K-Number: K970511 · 1997-08-12

Decision Date1997-08-12

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DYONICS DISPOSABLE ENDOSCOPIC SURGERY 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 1997-08-12 under 510(k) number K970511. 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 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES?

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K970511.

When did DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES receive FDA 510(k) clearance?

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES received FDA 510(k) clearance on 1997-08-12, under 510(k) number K970511.

Who is the listed applicant for DYONICS DISPOSABLE ENDOSCOPIC SURGERY 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 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES?

The FDA product code for DYONICS DISPOSABLE ENDOSCOPIC SURGERY 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.