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FDA 510(k)

ENTACT SEPTAL STAPLER, MODEL 610-00100

K-Number: K082750 · 2009-01-06

ApplicantEntrigue Surgical, Inc.
Decision Date2009-01-06
Product CodeOLL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENTACT SEPTAL STAPLER, MODEL 610-00100 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 2009-01-06 under 510(k) number K082750. The device is classified under product code OLL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTACT SEPTAL STAPLER, MODEL 610-00100?

ENTACT SEPTAL STAPLER, MODEL 610-00100 is a medical device that received FDA 510(k) clearance on 2009-01-06. The listed applicant is Entrigue Surgical, Inc.. The 510(k) number is K082750.

When did ENTACT SEPTAL STAPLER, MODEL 610-00100 receive FDA 510(k) clearance?

ENTACT SEPTAL STAPLER, MODEL 610-00100 received FDA 510(k) clearance on 2009-01-06, under 510(k) number K082750.

Who is the listed applicant for ENTACT SEPTAL STAPLER, MODEL 610-00100?

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 ENTACT SEPTAL STAPLER, MODEL 610-00100?

The FDA product code for ENTACT SEPTAL STAPLER, MODEL 610-00100 is OLL.

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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 SYSTEMK072470BIOELAST 5-0 SUTURE, MODEL 500100

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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