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FDA 510(k)

DRAPES

K-Number: K924335 · 1993-09-07

ApplicantPfb Inter-Apparel Corp.
Decision Date1993-09-07
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Pfb Inter-Apparel Corp.. It received FDA 510(k) clearance on 1993-09-07 under 510(k) number K924335. 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 DRAPES?

DRAPES is a medical device that received FDA 510(k) clearance on 1993-09-07. The listed applicant is Pfb Inter-Apparel Corp.. The 510(k) number is K924335.

When did DRAPES receive FDA 510(k) clearance?

DRAPES received FDA 510(k) clearance on 1993-09-07, under 510(k) number K924335.

Who is the listed applicant for DRAPES?

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

What is the FDA product code for DRAPES?

The FDA product code for DRAPES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pfb Inter-Apparel 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.

K922442ISOLATION GOWNS

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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