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)

PERCU GUIDE I (LOOP TYPE)

K-Number: K863090 · 1986-08-29

ApplicantE-Z-Em, Inc.
Decision Date1986-08-29
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERCU GUIDE I (LOOP TYPE) is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1986-08-29 under 510(k) number K863090. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCU GUIDE I (LOOP TYPE)?

PERCU GUIDE I (LOOP TYPE) is a medical device that received FDA 510(k) clearance on 1986-08-29. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K863090.

When did PERCU GUIDE I (LOOP TYPE) receive FDA 510(k) clearance?

PERCU GUIDE I (LOOP TYPE) received FDA 510(k) clearance on 1986-08-29, under 510(k) number K863090.

Who is the listed applicant for PERCU GUIDE I (LOOP TYPE)?

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

What is the FDA product code for PERCU GUIDE I (LOOP TYPE)?

The FDA product code for PERCU GUIDE I (LOOP TYPE) is GDF.

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 E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

View all 56 devices →

Related Devices (Code: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, 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.

↑