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FDA 510(k)

THORACENTISIS KIT

K-Number: K894326 · 1989-07-24

ApplicantMill-Rose Laboratory
Decision Date1989-07-24
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THORACENTISIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1989-07-24 under 510(k) number K894326. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THORACENTISIS KIT?

THORACENTISIS KIT is a medical device that received FDA 510(k) clearance on 1989-07-24. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K894326.

When did THORACENTISIS KIT receive FDA 510(k) clearance?

THORACENTISIS KIT received FDA 510(k) clearance on 1989-07-24, under 510(k) number K894326.

Who is the listed applicant for THORACENTISIS KIT?

The FDA 510(k) record lists Mill-Rose Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THORACENTISIS KIT?

The FDA product code for THORACENTISIS KIT is GAA.

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Other records listing Mill-Rose Laboratory 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.

K983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITK983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITK971275MILL-ROSE DISPOSABLE POLYPECTOMY SNAREK962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLEK960880MILL-ROSE BLIND MICROBIOLOGY BRUSHK954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

View all 46 devices →

Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, 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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