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FDA 510(k)

DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER

K-Number: K944435 · 1994-11-15

ApplicantDeroyal Industries, Inc.
Decision Date1994-11-15
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1994-11-15 under 510(k) number K944435. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER?

DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K944435.

When did DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER receive FDA 510(k) clearance?

DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER received FDA 510(k) clearance on 1994-11-15, under 510(k) number K944435.

Who is the listed applicant for DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER?

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

What is the FDA product code for DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER?

The FDA product code for DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER is OCW.

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Related Devices (Code: OCW)

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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.

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