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FDA 510(k)

BARRIER APERTURED DRAPE

K-Number: K801864 · 1980-08-20

ApplicantSurgikos, Inc.
Decision Date1980-08-20
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER APERTURED DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801864. 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 BARRIER APERTURED DRAPE?

BARRIER APERTURED DRAPE is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Surgikos, Inc.. The 510(k) number is K801864.

When did BARRIER APERTURED DRAPE receive FDA 510(k) clearance?

BARRIER APERTURED DRAPE received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801864.

Who is the listed applicant for BARRIER APERTURED DRAPE?

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

What is the FDA product code for BARRIER APERTURED DRAPE?

The FDA product code for BARRIER APERTURED DRAPE is KKX.

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Other records listing Surgikos, 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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE 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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