FDA 510(k)

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

K-Number: K040415 · 2004-04-14

Decision Date2004-04-14

Product CodeDXZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Surgical Innovations. It received FDA 510(k) clearance on 2004-04-14 under 510(k) number K040415. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT?

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT is a medical device that received FDA 510(k) clearance on 2004-04-14. The listed applicant is Synovis Surgical Innovations. The 510(k) number is K040415.

When did PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT receive FDA 510(k) clearance?

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT received FDA 510(k) clearance on 2004-04-14, under 510(k) number K040415.

Who is the listed applicant for PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT?

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

What is the FDA product code for PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT?

The FDA product code for PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT is DXZ.

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Other records listing Synovis Surgical Innovations as applicant

K122306SYNOVIS COLLAGEN MATRIX (TBD)K083039VERITAS COLLAGEN MATRIX (DRY)K062915VERITAS COLLAGEN MATRIX K041669VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD K040119PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION K040001STEERABLE STYLET

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Related Devices (Code: DXZ)

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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.