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FDA 510(k)

STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE

K-Number: K905466 · 1991-02-11

ApplicantAngiosystems, Inc.
Decision Date1991-02-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Angiosystems, Inc.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905466. 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 STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE?

STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Angiosystems, Inc.. The 510(k) number is K905466.

When did STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE receive FDA 510(k) clearance?

STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905466.

Who is the listed applicant for STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE?

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

What is the FDA product code for STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE?

The FDA product code for STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE is KKX.

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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 Angiosystems, 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.

K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLINGK905459SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOMK905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESK905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPEK905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYK905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES

View all 14 devices →

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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