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FDA 510(k)

DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS

K-Number: K981239 · 1998-05-14

ApplicantDeroyal Surgical
Decision Date1998-05-14
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Surgical. It received FDA 510(k) clearance on 1998-05-14 under 510(k) number K981239. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS?

DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is a medical device that received FDA 510(k) clearance on 1998-05-14. The listed applicant is Deroyal Surgical. The 510(k) number is K981239.

When did DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS receive FDA 510(k) clearance?

DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS received FDA 510(k) clearance on 1998-05-14, under 510(k) number K981239.

Who is the listed applicant for DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS?

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

What is the FDA product code for DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS?

The FDA product code for DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is FZP.

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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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