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FDA 510(k)

SHELHIGH NO-REACT BIOCUFF

K-Number: K032893 · 2003-12-19

ApplicantShelhigh, Inc.
Decision Date2003-12-19
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHELHIGH NO-REACT BIOCUFF is the device name listed in this FDA 510(k) record. The listed applicant is Shelhigh, Inc.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K032893. 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 SHELHIGH NO-REACT BIOCUFF?

SHELHIGH NO-REACT BIOCUFF is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Shelhigh, Inc.. The 510(k) number is K032893.

When did SHELHIGH NO-REACT BIOCUFF receive FDA 510(k) clearance?

SHELHIGH NO-REACT BIOCUFF received FDA 510(k) clearance on 2003-12-19, under 510(k) number K032893.

Who is the listed applicant for SHELHIGH NO-REACT BIOCUFF?

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

What is the FDA product code for SHELHIGH NO-REACT BIOCUFF?

The FDA product code for SHELHIGH NO-REACT BIOCUFF is FTL.

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Other records listing Shelhigh, 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.

K023940SHELHIGH BIORINGK982101SHELHIGH NO-REACT DURA SHIELDK991567SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.K982810SHELHIGH NO-REACT VASCUPATCHK981756SHELHIGH NO-REACT PNEUMOPLEDGETSK974914SHELHIGH NO-REACT PERICARDIAL PATCHES

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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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