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FDA 510(k)

PAINBUSTER INFUSION SYSTEM

K-Number: K980558 · 1998-05-28

ApplicantI-Flow Corp.
Decision Date1998-05-28
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PAINBUSTER INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is I-Flow Corp.. It received FDA 510(k) clearance on 1998-05-28 under 510(k) number K980558. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAINBUSTER INFUSION SYSTEM?

PAINBUSTER INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-28. The listed applicant is I-Flow Corp.. The 510(k) number is K980558.

When did PAINBUSTER INFUSION SYSTEM receive FDA 510(k) clearance?

PAINBUSTER INFUSION SYSTEM received FDA 510(k) clearance on 1998-05-28, under 510(k) number K980558.

Who is the listed applicant for PAINBUSTER INFUSION SYSTEM?

The FDA 510(k) record lists I-Flow Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAINBUSTER INFUSION SYSTEM?

The FDA product code for PAINBUSTER INFUSION SYSTEM is MEB.

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.

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Other records listing I-Flow Corp. 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.

K063530ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMPK063234ON-Q INTRODUCERSK051401ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETERK052117I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)K043456MODIFICATION TO SOAKER CATHETERK040337I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)

View all 41 devices →

Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, 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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