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FDA 510(k)

TRANQUILL BARBED DEVICE

K-Number: K133420 · 2013-11-29

ApplicantSurgical Specialties Corp. Dba Angiotech
Decision Date2013-11-29
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRANQUILL BARBED DEVICE 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 2013-11-29 under 510(k) number K133420. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANQUILL BARBED DEVICE?

TRANQUILL BARBED DEVICE is a medical device that received FDA 510(k) clearance on 2013-11-29. The listed applicant is Surgical Specialties Corp. Dba Angiotech. The 510(k) number is K133420.

When did TRANQUILL BARBED DEVICE receive FDA 510(k) clearance?

TRANQUILL BARBED DEVICE received FDA 510(k) clearance on 2013-11-29, under 510(k) number K133420.

Who is the listed applicant for TRANQUILL BARBED DEVICE?

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 TRANQUILL BARBED DEVICE?

The FDA product code for TRANQUILL BARBED DEVICE is NEW.

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Other records listing Surgical Specialties Corp. Dba Angiotech 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.

K131224SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSUREK130078QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNK123877QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNK123836QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNK123409QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNK122898QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

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Related Devices (Code: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.

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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