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FDA 510(k)

SUNMED FOLEY CATHETERS

K-Number: K062112 · 2007-06-04

ApplicantSunmed, Inc.
Decision Date2007-06-04
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUNMED FOLEY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Sunmed, Inc.. It received FDA 510(k) clearance on 2007-06-04 under 510(k) number K062112. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNMED FOLEY CATHETERS?

SUNMED FOLEY CATHETERS is a medical device that received FDA 510(k) clearance on 2007-06-04. The listed applicant is Sunmed, Inc.. The 510(k) number is K062112.

When did SUNMED FOLEY CATHETERS receive FDA 510(k) clearance?

SUNMED FOLEY CATHETERS received FDA 510(k) clearance on 2007-06-04, under 510(k) number K062112.

Who is the listed applicant for SUNMED FOLEY CATHETERS?

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

What is the FDA product code for SUNMED FOLEY CATHETERS?

The FDA product code for SUNMED FOLEY CATHETERS is EZL.

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 Sunmed, 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.

K955631ORTHOPLUG HARD BONE DESIGNK955632ORTHOPLUG SOFT BONE DESIGNK921263SUNLITE LARYNGOSCOPE

Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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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