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FDA 510(k)

ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH

K-Number: K030631 · 2003-05-19

ApplicantProsurg, Inc.
Decision Date2003-05-19
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2003-05-19 under 510(k) number K030631. 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 ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH?

ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2003-05-19. The listed applicant is Prosurg, Inc.. The 510(k) number is K030631.

When did ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH receive FDA 510(k) clearance?

ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH received FDA 510(k) clearance on 2003-05-19, under 510(k) number K030631.

Who is the listed applicant for ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH?

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

What is the FDA product code for ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH?

The FDA product code for ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH is FTL.

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Related Devices (Code: FTL)

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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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