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FDA 510(k)

SHUR-PATCH TAPE PATCH

K-Number: K803012 · 1980-12-30

ApplicantShur Medical Corp.
Decision Date1980-12-30
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SHUR-PATCH TAPE PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Shur Medical Corp.. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K803012. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUR-PATCH TAPE PATCH?

SHUR-PATCH TAPE PATCH is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is Shur Medical Corp.. The 510(k) number is K803012.

When did SHUR-PATCH TAPE PATCH receive FDA 510(k) clearance?

SHUR-PATCH TAPE PATCH received FDA 510(k) clearance on 1980-12-30, under 510(k) number K803012.

Who is the listed applicant for SHUR-PATCH TAPE PATCH?

The FDA 510(k) record lists Shur Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHUR-PATCH TAPE PATCH?

The FDA product code for SHUR-PATCH TAPE PATCH is GXY.

Related Clinical Trials

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.

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Other records listing Shur Medical Corp. 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.

K821763SHUR-STRIP APPLICATORK790140SKIN CLOSURE TAPES STERILE

Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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