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FDA 510(k)

BIOELAST 5-0 SUTURE, MODEL 500100

K-Number: K072470 · 2007-11-16

ApplicantEntrigue Surgical, Inc.
Decision Date2007-11-16
Product CodeNWJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOELAST 5-0 SUTURE, MODEL 500100 is the device name listed in this FDA 510(k) record. The listed applicant is Entrigue Surgical, Inc.. It received FDA 510(k) clearance on 2007-11-16 under 510(k) number K072470. The device is classified under product code NWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOELAST 5-0 SUTURE, MODEL 500100?

BIOELAST 5-0 SUTURE, MODEL 500100 is a medical device that received FDA 510(k) clearance on 2007-11-16. The listed applicant is Entrigue Surgical, Inc.. The 510(k) number is K072470.

When did BIOELAST 5-0 SUTURE, MODEL 500100 receive FDA 510(k) clearance?

BIOELAST 5-0 SUTURE, MODEL 500100 received FDA 510(k) clearance on 2007-11-16, under 510(k) number K072470.

Who is the listed applicant for BIOELAST 5-0 SUTURE, MODEL 500100?

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

What is the FDA product code for BIOELAST 5-0 SUTURE, MODEL 500100?

The FDA product code for BIOELAST 5-0 SUTURE, MODEL 500100 is NWJ.

Related Clinical Trials

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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Other records listing Entrigue Surgical, Inc. 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.

K130354MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)K121351SINUS DILATION SYSTEMK082750ENTACT SEPTAL STAPLER, MODEL 610-00100

Related Devices (Code: NWJ)

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.

K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc.K132348TEPHAFLEX BRAIDED SUTURETepha, Inc.K130422PHANTOM FIBER BIOFIBER SUTURETornier, Inc.K122487BIOFIBER SYTURETornier, Inc.K100876AESCULAP MONOMAX ABSORBABLE SUTUREAesculap, Inc.K082178TEPHAFLEX ABSORBABLE SUTURETepha, 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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