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FDA 510(k)

PLC SUTURE ANCHOR

K-Number: K063726 · 2007-03-06

ApplicantSmith & Nephew Inc., Endoscopy Div.
Decision Date2007-03-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLC SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2007-03-06 under 510(k) number K063726. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLC SUTURE ANCHOR?

PLC SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2007-03-06. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K063726.

When did PLC SUTURE ANCHOR receive FDA 510(k) clearance?

PLC SUTURE ANCHOR received FDA 510(k) clearance on 2007-03-06, under 510(k) number K063726.

Who is the listed applicant for PLC SUTURE ANCHOR?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLC SUTURE ANCHOR?

The FDA product code for PLC SUTURE ANCHOR is HRS.

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Other records listing Smith & Nephew Inc., Endoscopy Div. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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