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)

QUALTEX SURGICAL DRAPE, MODIFICATION

K-Number: K913486 · 1992-02-05

ApplicantDeroyal Industries, Inc.
Decision Date1992-02-05
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX SURGICAL DRAPE, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1992-02-05 under 510(k) number K913486. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALTEX SURGICAL DRAPE, MODIFICATION?

QUALTEX SURGICAL DRAPE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-02-05. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K913486.

When did QUALTEX SURGICAL DRAPE, MODIFICATION receive FDA 510(k) clearance?

QUALTEX SURGICAL DRAPE, MODIFICATION received FDA 510(k) clearance on 1992-02-05, under 510(k) number K913486.

Who is the listed applicant for QUALTEX SURGICAL DRAPE, MODIFICATION?

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

What is the FDA product code for QUALTEX SURGICAL DRAPE, MODIFICATION?

The FDA product code for QUALTEX SURGICAL DRAPE, MODIFICATION is KKX.

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 Industries, 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.

K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryK230233Prospera Spectruum Negative Pressure Wound Therapy SystemK200631DeRoyal Temperature Monitoring ProbeK200757Foley Catheter with Temperature SensorK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

View all 90 devices →

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.

↑