FDA 510(k)

SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT

K-Number: K971230 · 1997-06-13

Decision Date1997-06-13

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K971230. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT?

SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Innerdyne, Inc.. The 510(k) number is K971230.

When did SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT receive FDA 510(k) clearance?

SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT received FDA 510(k) clearance on 1997-06-13, under 510(k) number K971230.

Who is the listed applicant for SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT?

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

What is the FDA product code for SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT?

The FDA product code for SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT is KNT.

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Other records listing Innerdyne, Inc. as applicant

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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.