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FDA 510(k)

BLADEWORKS DISPOSABLE ALK TUBING

K-Number: K993591 · 1999-12-28

ApplicantBlade Works, Inc.
Decision Date1999-12-28
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLADEWORKS DISPOSABLE ALK TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Blade Works, Inc.. It received FDA 510(k) clearance on 1999-12-28 under 510(k) number K993591. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADEWORKS DISPOSABLE ALK TUBING?

BLADEWORKS DISPOSABLE ALK TUBING is a medical device that received FDA 510(k) clearance on 1999-12-28. The listed applicant is Blade Works, Inc.. The 510(k) number is K993591.

When did BLADEWORKS DISPOSABLE ALK TUBING receive FDA 510(k) clearance?

BLADEWORKS DISPOSABLE ALK TUBING received FDA 510(k) clearance on 1999-12-28, under 510(k) number K993591.

Who is the listed applicant for BLADEWORKS DISPOSABLE ALK TUBING?

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

What is the FDA product code for BLADEWORKS DISPOSABLE ALK TUBING?

The FDA product code for BLADEWORKS DISPOSABLE ALK TUBING is KYG.

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 Blade Works, 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.

K020079BLADEWORKS MICROKERATOME BLADE, MODEL 7061K993225BLADEWORKS MICROKERATOME BLADE

Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.K971173ML DISPOSABLE ALK TUBINGMed-Logics, Inc.

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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