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FDA 510(k)

BRAIDED POLYESTER SUTURE MATERIAL

K-Number: K923161 · 1992-12-30

ApplicantMitek Surgical Products, Inc.
Decision Date1992-12-30
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BRAIDED POLYESTER SUTURE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Surgical Products, Inc.. It received FDA 510(k) clearance on 1992-12-30 under 510(k) number K923161. The device is classified under product code GAS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIDED POLYESTER SUTURE MATERIAL?

BRAIDED POLYESTER SUTURE MATERIAL is a medical device that received FDA 510(k) clearance on 1992-12-30. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K923161.

When did BRAIDED POLYESTER SUTURE MATERIAL receive FDA 510(k) clearance?

BRAIDED POLYESTER SUTURE MATERIAL received FDA 510(k) clearance on 1992-12-30, under 510(k) number K923161.

Who is the listed applicant for BRAIDED POLYESTER SUTURE MATERIAL?

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

What is the FDA product code for BRAIDED POLYESTER SUTURE MATERIAL?

The FDA product code for BRAIDED POLYESTER SUTURE MATERIAL is GAS.

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Other records listing Mitek Surgical Products, 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.

K953560MITEK THREADED ANCHOR (FASTIN)K953877MITEK GII ANCHORK936311MITEK MINI ANCHORK941599MITEK ABSORBABLE ANCHORK944051ABSORBALBE ANCHORK950070MITEK TOGGLE ANCHOR(TM)

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Related Devices (Code: GAS)

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.

K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc.K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi SolutionsK091018ARTHREX BIOWIREArthrex, Inc.K002261MR-IIISmith & Nephew, Inc.K953128SUTURE CORDPhoenix Biomedical Corp.K913101PETERS CARDIOFLON(TM) SUTUREPromedica Products, 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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