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FDA 510(k)

IMPERVIOUS STOCKINET

K-Number: K781046 · 1978-08-18

ApplicantSpartan Healthcare Products Co.
Decision Date1978-08-18
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPERVIOUS STOCKINET is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Healthcare Products Co.. It received FDA 510(k) clearance on 1978-08-18 under 510(k) number K781046. 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 IMPERVIOUS STOCKINET?

IMPERVIOUS STOCKINET is a medical device that received FDA 510(k) clearance on 1978-08-18. The listed applicant is Spartan Healthcare Products Co.. The 510(k) number is K781046.

When did IMPERVIOUS STOCKINET receive FDA 510(k) clearance?

IMPERVIOUS STOCKINET received FDA 510(k) clearance on 1978-08-18, under 510(k) number K781046.

Who is the listed applicant for IMPERVIOUS STOCKINET?

The FDA 510(k) record lists Spartan Healthcare Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPERVIOUS STOCKINET?

The FDA product code for IMPERVIOUS STOCKINET 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 Spartan Healthcare Products Co. 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.

K781047DRAPE, SURGICAL-SPARTAN LIMB SHEET

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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