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)

BUSSE SURGICAL DRAPES IV

K-Number: K093909 · 2010-05-06

ApplicantBusse Hospital Disposables, Inc.
Decision Date2010-05-06
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BUSSE SURGICAL DRAPES IV is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 2010-05-06 under 510(k) number K093909. 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 BUSSE SURGICAL DRAPES IV?

BUSSE SURGICAL DRAPES IV is a medical device that received FDA 510(k) clearance on 2010-05-06. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K093909.

When did BUSSE SURGICAL DRAPES IV receive FDA 510(k) clearance?

BUSSE SURGICAL DRAPES IV received FDA 510(k) clearance on 2010-05-06, under 510(k) number K093909.

Who is the listed applicant for BUSSE SURGICAL DRAPES IV?

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

What is the FDA product code for BUSSE SURGICAL DRAPES IV?

The FDA product code for BUSSE SURGICAL DRAPES IV 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 Busse Hospital Disposables, 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.

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEK092212BUSSE SURGICAL DRAPES IIIK082297BUSSE SURGICAL DRAPEK073222MODIFICATION TO:SPECIALTY NEEDLESK070465BUSSE EPIDURAL CATHETERK063018GLASS LOSS OF RESISTANCE SYRINGE

View all 31 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.

↑