FDA 510(k)

DYONICS INTELIJET INFLOW/OUTFLOW CANNULA

K-Number: K981156 · 1998-05-20

Decision Date1998-05-20

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DYONICS INTELIJET INFLOW/OUTFLOW CANNULA 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 1998-05-20 under 510(k) number K981156. 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 INTELIJET INFLOW/OUTFLOW CANNULA?

DYONICS INTELIJET INFLOW/OUTFLOW CANNULA is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K981156.

When did DYONICS INTELIJET INFLOW/OUTFLOW CANNULA receive FDA 510(k) clearance?

DYONICS INTELIJET INFLOW/OUTFLOW CANNULA received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981156.

Who is the listed applicant for DYONICS INTELIJET INFLOW/OUTFLOW CANNULA?

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 INTELIJET INFLOW/OUTFLOW CANNULA?

The FDA product code for DYONICS INTELIJET INFLOW/OUTFLOW CANNULA 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.