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FDA 510(k)

PHOENIX ETE TISSUE EXTENSION SYSTEM

K-Number: K962144 · 1997-01-14

ApplicantPhoenix Biomedical Corp.
Decision Date1997-01-14
Product CodeMKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOENIX ETE TISSUE EXTENSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Biomedical Corp.. It received FDA 510(k) clearance on 1997-01-14 under 510(k) number K962144. The device is classified under product code MKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX ETE TISSUE EXTENSION SYSTEM?

PHOENIX ETE TISSUE EXTENSION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-14. The listed applicant is Phoenix Biomedical Corp.. The 510(k) number is K962144.

When did PHOENIX ETE TISSUE EXTENSION SYSTEM receive FDA 510(k) clearance?

PHOENIX ETE TISSUE EXTENSION SYSTEM received FDA 510(k) clearance on 1997-01-14, under 510(k) number K962144.

Who is the listed applicant for PHOENIX ETE TISSUE EXTENSION SYSTEM?

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

What is the FDA product code for PHOENIX ETE TISSUE EXTENSION SYSTEM?

The FDA product code for PHOENIX ETE TISSUE EXTENSION SYSTEM is MKY.

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Other records listing Phoenix Biomedical 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.

K030468ACURA ELITE GRAVITY COMPENSATING RESERVOIRK024101PHOENIX UNIVERSAL SHUNT SYSTEMK024040ACCURA ELITE SHUNT SYSTEMK021644PERF (OMMAYA STYLE) RESERVOIRSK002476LUMBOPERITONEAL SHUNT SYSTEMK000514RUMBAR DRAINAGE SYSTEM

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Related Devices (Code: MKY)

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.

K002315WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.K942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, 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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