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)

DEROYAL SURGICAL, UMBILICUP

K-Number: K020753 · 2002-06-13

ApplicantDeroyal
Decision Date2002-06-13
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DEROYAL SURGICAL, UMBILICUP is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K020753. The device is classified under product code KSR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL SURGICAL, UMBILICUP?

DEROYAL SURGICAL, UMBILICUP is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Deroyal. The 510(k) number is K020753.

When did DEROYAL SURGICAL, UMBILICUP receive FDA 510(k) clearance?

DEROYAL SURGICAL, UMBILICUP received FDA 510(k) clearance on 2002-06-13, under 510(k) number K020753.

Who is the listed applicant for DEROYAL SURGICAL, UMBILICUP?

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

What is the FDA product code for DEROYAL SURGICAL, UMBILICUP?

The FDA product code for DEROYAL SURGICAL, UMBILICUP is KSR.

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 Deroyal 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.

K041416EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETERK033057DEROYAL SURGICAL GOWNS, STERILE, NON-STERILEK031408DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)K030908DEROYAL SURGICAL DRAPES BACKTABLE COVER

Related Devices (Code: KSR)

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.

K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco HealthcareK810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.K810500BLOOD FREEZING BAGDelmed, Inc.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.K810711HAEMONETICS 600 ML. COMPONENT BAGHaemonetics Corp.

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.

↑