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FDA 510(k)

NONWOVEN SURGICAL DRAPE PACK

K-Number: K862062 · 1986-06-10

ApplicantEast Texas Lighthouse For the Blind
Decision Date1986-06-10
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NONWOVEN SURGICAL DRAPE PACK is the device name listed in this FDA 510(k) record. The listed applicant is East Texas Lighthouse For the Blind. It received FDA 510(k) clearance on 1986-06-10 under 510(k) number K862062. 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 NONWOVEN SURGICAL DRAPE PACK?

NONWOVEN SURGICAL DRAPE PACK is a medical device that received FDA 510(k) clearance on 1986-06-10. The listed applicant is East Texas Lighthouse For the Blind. The 510(k) number is K862062.

When did NONWOVEN SURGICAL DRAPE PACK receive FDA 510(k) clearance?

NONWOVEN SURGICAL DRAPE PACK received FDA 510(k) clearance on 1986-06-10, under 510(k) number K862062.

Who is the listed applicant for NONWOVEN SURGICAL DRAPE PACK?

The FDA 510(k) record lists East Texas Lighthouse For the Blind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NONWOVEN SURGICAL DRAPE PACK?

The FDA product code for NONWOVEN SURGICAL DRAPE PACK 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.

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Other records listing East Texas Lighthouse For the Blind 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.

K883376STERILIZATION WRAP TYPE 22,44,77K882275STERILE PACK (PROCEDURAL TRAY/KITS)K863733TOWEL PACK, SURGICALK850067MEDICAL, DISPOSABLE BEDDINGK850811PAD, PRE-OPERATIVE PREPARATIONK850016TOWEL PACK, SURGICAL

View all 7 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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