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FDA 510(k)

CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM

K-Number: K902401 · 1991-10-08

ApplicantBurron Medical, Inc.
Decision Date1991-10-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical, Inc.. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K902401. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM?

CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Burron Medical, Inc.. The 510(k) number is K902401.

When did CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM receive FDA 510(k) clearance?

CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM received FDA 510(k) clearance on 1991-10-08, under 510(k) number K902401.

Who is the listed applicant for CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM?

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

What is the FDA product code for CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM?

The FDA product code for CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM is FMF.

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Other records listing Burron Medical, 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.

K896422BURRON AMBULATORY DRUG DELIVERY SYSTEMK884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KITK895191ANTI-THROMBOGENIC COATING FOR CATHETERSK895192SPINOCAN(R) CONTINUOUS SPINAL TRAYK884183BURRON TEFLON-COATED GUIDEWIREK882106PERFUSOR M SYRINGE PUMP

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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