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FDA 510(k)

DRAPE, SURGICAL-LATEX

K-Number: K970891 · 1997-08-22

ApplicantProtek Medical Products, Inc.
Decision Date1997-08-22
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPE, SURGICAL-LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Protek Medical Products, Inc.. It received FDA 510(k) clearance on 1997-08-22 under 510(k) number K970891. 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-LATEX?

DRAPE, SURGICAL-LATEX is a medical device that received FDA 510(k) clearance on 1997-08-22. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K970891.

When did DRAPE, SURGICAL-LATEX receive FDA 510(k) clearance?

DRAPE, SURGICAL-LATEX received FDA 510(k) clearance on 1997-08-22, under 510(k) number K970891.

Who is the listed applicant for DRAPE, SURGICAL-LATEX?

The FDA 510(k) record lists Protek Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAPE, SURGICAL-LATEX?

The FDA product code for DRAPE, SURGICAL-LATEX is KKX.

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Other records listing Protek Medical Products, 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.

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITK973622TRANSDUCER POSITIONERK970893ULTRASOUND TRANSDUCER DRAPEK970889ULTRASOUND TRANSDUCER DRAPEK973362NEEDLE GUIDE/GRIDK970885ULTRASOUND SYSTEMS DRAPE

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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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