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FDA 510(k)

DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE

K-Number: K083320 · 2009-03-06

ApplicantDukal Corp.
Decision Date2009-03-06
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corp.. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K083320. 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 DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE?

DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Dukal Corp.. The 510(k) number is K083320.

When did DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE receive FDA 510(k) clearance?

DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE received FDA 510(k) clearance on 2009-03-06, under 510(k) number K083320.

Who is the listed applicant for DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE?

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

What is the FDA product code for DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE?

The FDA product code for DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE is KKX.

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Other records listing Dukal Corp. 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.

K070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUEK061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEK984564ETHYL CHLORIDE DISPENSERK970457DUKAL ABD COMBINE PADK970455DUKAL NON ADHERENT DRESSING

View all 11 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.

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