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FDA 510(k)

SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS

K-Number: K040602 · 2004-05-10

ApplicantDesign Standards Corp.
Decision Date2004-05-10
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is the device name listed in this FDA 510(k) record. The listed applicant is Design Standards Corp.. It received FDA 510(k) clearance on 2004-05-10 under 510(k) number K040602. 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 SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS?

SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is a medical device that received FDA 510(k) clearance on 2004-05-10. The listed applicant is Design Standards Corp.. The 510(k) number is K040602.

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

SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS received FDA 510(k) clearance on 2004-05-10, under 510(k) number K040602.

Who is the listed applicant for SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS?

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

What is the FDA product code for SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS?

The FDA product code for SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS is FZP.

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Related Devices (Code: 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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