FDA 510(k)

INSORB ABSORBABLE STAPLE, MODEL 1020

K-Number: K061784 · 2006-07-26

Decision Date2006-07-26

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

INSORB ABSORBABLE STAPLE, MODEL 1020 is the device name listed in this FDA 510(k) record. The listed applicant is Incisive Surgical, Inc.. It received FDA 510(k) clearance on 2006-07-26 under 510(k) number K061784. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSORB ABSORBABLE STAPLE, MODEL 1020?

INSORB ABSORBABLE STAPLE, MODEL 1020 is a medical device that received FDA 510(k) clearance on 2006-07-26. The listed applicant is Incisive Surgical, Inc.. The 510(k) number is K061784.

When did INSORB ABSORBABLE STAPLE, MODEL 1020 receive FDA 510(k) clearance?

INSORB ABSORBABLE STAPLE, MODEL 1020 received FDA 510(k) clearance on 2006-07-26, under 510(k) number K061784.

Who is the listed applicant for INSORB ABSORBABLE STAPLE, MODEL 1020?

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

What is the FDA product code for INSORB ABSORBABLE STAPLE, MODEL 1020?

The FDA product code for INSORB ABSORBABLE STAPLE, MODEL 1020 is GDW.

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Other records listing Incisive Surgical, Inc. as applicant

K120373INSORB ABSORBALBE STAPLE K090159INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES K033602INSORB ABSORBABLE STAPLE, MODEL SP-B20 K024117INSORB ABSORBABLE STAPLES, MODEL SP-B20

Related Devices (Code: GDW)

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.