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FDA 510(k)

VIVOSORB SHEET, MODEL FS01

K-Number: K042811 · 2004-11-08

ApplicantPolyganics B.V.,
Decision Date2004-11-08
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIVOSORB SHEET, MODEL FS01 is the device name listed in this FDA 510(k) record. The listed applicant is Polyganics B.V.,. It received FDA 510(k) clearance on 2004-11-08 under 510(k) number K042811. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVOSORB SHEET, MODEL FS01?

VIVOSORB SHEET, MODEL FS01 is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Polyganics B.V.,. The 510(k) number is K042811.

When did VIVOSORB SHEET, MODEL FS01 receive FDA 510(k) clearance?

VIVOSORB SHEET, MODEL FS01 received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042811.

Who is the listed applicant for VIVOSORB SHEET, MODEL FS01?

The FDA 510(k) record lists Polyganics B.V., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVOSORB SHEET, MODEL FS01?

The FDA product code for VIVOSORB SHEET, MODEL FS01 is FTL.

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Other records listing Polyganics B.V., 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.

K112267NEUROLAC(R) NERVE GUIDEK070715NASOPORE EARK062540NASOPORE EAR, MODELS ND04, ND05K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZK050573NEUROLAC NERVE GUIDEK032115NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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