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FDA 510(k)

TLS BULB DRAINAGE SYSTEM

K-Number: K833586 · 1984-01-30

ApplicantPorex Medical
Decision Date1984-01-30
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TLS BULB DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Porex Medical. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K833586. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TLS BULB DRAINAGE SYSTEM?

TLS BULB DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Porex Medical. The 510(k) number is K833586.

When did TLS BULB DRAINAGE SYSTEM receive FDA 510(k) clearance?

TLS BULB DRAINAGE SYSTEM received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833586.

Who is the listed applicant for TLS BULB DRAINAGE SYSTEM?

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

What is the FDA product code for TLS BULB DRAINAGE SYSTEM?

The FDA product code for TLS BULB DRAINAGE SYSTEM is GCY.

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Other records listing Porex Medical 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.

K872791POREX NERVE LOCATORK873044POREX OTOLOGY INSTRUMENTSK872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSK863946POREX(TM) EXTRA-OCULAR ORBITAL IMPLANTK863943POREX(TM) EYE SPHERE IMPLANTK870257POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.

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Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 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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