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FDA 510(k)

DRAPE SURGICAL UTILITY DRAPE STERILE

K-Number: K843496 · 1984-10-31

ApplicantBusse Hospital Disposables, Inc.
Decision Date1984-10-31
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPE SURGICAL UTILITY DRAPE STERILE 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 1984-10-31 under 510(k) number K843496. 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 DRAPE SURGICAL UTILITY DRAPE STERILE?

DRAPE SURGICAL UTILITY DRAPE STERILE is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K843496.

When did DRAPE SURGICAL UTILITY DRAPE STERILE receive FDA 510(k) clearance?

DRAPE SURGICAL UTILITY DRAPE STERILE received FDA 510(k) clearance on 1984-10-31, under 510(k) number K843496.

Who is the listed applicant for DRAPE SURGICAL UTILITY DRAPE STERILE?

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 DRAPE SURGICAL UTILITY DRAPE STERILE?

The FDA product code for DRAPE SURGICAL UTILITY DRAPE STERILE is KKX.

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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-HANDLEK093909BUSSE SURGICAL DRAPES IVK092212BUSSE SURGICAL DRAPES IIIK082297BUSSE SURGICAL DRAPEK073222MODIFICATION TO:SPECIALTY NEEDLESK070465BUSSE EPIDURAL CATHETER

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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.

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