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FDA 510(k)

STERILESERT(TM) CABLE AND POLE DRAPE

K-Number: K913047 · 1991-10-02

ApplicantArch Development Group
Decision Date1991-10-02
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILESERT(TM) CABLE AND POLE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Arch Development Group. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K913047. 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 STERILESERT(TM) CABLE AND POLE DRAPE?

STERILESERT(TM) CABLE AND POLE DRAPE is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Arch Development Group. The 510(k) number is K913047.

When did STERILESERT(TM) CABLE AND POLE DRAPE receive FDA 510(k) clearance?

STERILESERT(TM) CABLE AND POLE DRAPE received FDA 510(k) clearance on 1991-10-02, under 510(k) number K913047.

Who is the listed applicant for STERILESERT(TM) CABLE AND POLE DRAPE?

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

What is the FDA product code for STERILESERT(TM) CABLE AND POLE DRAPE?

The FDA product code for STERILESERT(TM) CABLE AND POLE DRAPE 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 Arch Development Group 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.

K912765STASIS BUTTON PRSSURE DEVICE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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