Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SHUR-STRIP APPLICATOR

K-Number: K821763 · 1982-06-23

ApplicantShur Medical Corp.
Decision Date1982-06-23
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHUR-STRIP APPLICATOR 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 1982-06-23 under 510(k) number K821763. The device is classified under product code FPX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUR-STRIP APPLICATOR?

SHUR-STRIP APPLICATOR is a medical device that received FDA 510(k) clearance on 1982-06-23. The listed applicant is Shur Medical Corp.. The 510(k) number is K821763.

When did SHUR-STRIP APPLICATOR receive FDA 510(k) clearance?

SHUR-STRIP APPLICATOR received FDA 510(k) clearance on 1982-06-23, under 510(k) number K821763.

Who is the listed applicant for SHUR-STRIP APPLICATOR?

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-STRIP APPLICATOR?

The FDA product code for SHUR-STRIP APPLICATOR is FPX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K803012SHUR-PATCH TAPE PATCHK790140SKIN CLOSURE TAPES STERILE

Related Devices (Code: FPX)

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.

K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.K952947DELPORE SKIN CLOSUREBitco Intl.K952702DERMA SEALTtl MedicalK946321BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.K931005DUKAL SKIN CLOSURE STRIPDukal Corp.K921775SPYROFLEX WOUND CLOSURESPolymint Industrial Co. , Ltd.

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.

↑