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FDA 510(k)

SPUNGUARD PLUS SURGICAL DRAPE

K-Number: K862801 · 1986-08-07

ApplicantKimberly-Clark Corp.
Decision Date1986-08-07
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPUNGUARD PLUS SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K862801. 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 SPUNGUARD PLUS SURGICAL DRAPE?

SPUNGUARD PLUS SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K862801.

When did SPUNGUARD PLUS SURGICAL DRAPE receive FDA 510(k) clearance?

SPUNGUARD PLUS SURGICAL DRAPE received FDA 510(k) clearance on 1986-08-07, under 510(k) number K862801.

Who is the listed applicant for SPUNGUARD PLUS SURGICAL DRAPE?

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

What is the FDA product code for SPUNGUARD PLUS SURGICAL DRAPE?

The FDA product code for SPUNGUARD PLUS SURGICAL DRAPE is KKX.

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Other records listing Kimberly-Clark Corp. as applicant

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K131879KC 300 SURGICAL MASKK131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVEK131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEK120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGK112805KIMGUARD ONE-STEP STERILIZATION WRAPK113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

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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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