FDA 510(k)

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE

K-Number: K131224 · 2013-05-16

ApplicantSurgical Specialties Corp. Dba Angiotech

Decision Date2013-05-16

Product CodeGAW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. Dba Angiotech. It received FDA 510(k) clearance on 2013-05-16 under 510(k) number K131224. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE?

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE is a medical device that received FDA 510(k) clearance on 2013-05-16. The listed applicant is Surgical Specialties Corp. Dba Angiotech. The 510(k) number is K131224.

When did SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE receive FDA 510(k) clearance?

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE received FDA 510(k) clearance on 2013-05-16, under 510(k) number K131224.

Who is the listed applicant for SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE?

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

What is the FDA product code for SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE?

The FDA product code for SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE is GAW.

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Other records listing Surgical Specialties Corp. Dba Angiotech as applicant

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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.