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FDA 510(k)

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.

K-Number: K991567 · 1999-07-14

ApplicantShelhigh, Inc.
Decision Date1999-07-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. is the device name listed in this FDA 510(k) record. The listed applicant is Shelhigh, Inc.. It received FDA 510(k) clearance on 1999-07-14 under 510(k) number K991567. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.?

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Shelhigh, Inc.. The 510(k) number is K991567.

When did SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. receive FDA 510(k) clearance?

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. received FDA 510(k) clearance on 1999-07-14, under 510(k) number K991567.

Who is the listed applicant for SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.?

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 TISSUE REPAIR PATCH/UROPATCH.?

The FDA product code for SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. is FTM.

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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.

K032893SHELHIGH NO-REACT BIOCUFFK023940SHELHIGH BIORINGK982101SHELHIGH NO-REACT DURA SHIELDK982810SHELHIGH NO-REACT VASCUPATCHK981756SHELHIGH NO-REACT PNEUMOPLEDGETSK974914SHELHIGH NO-REACT PERICARDIAL PATCHES

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Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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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