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FDA 510(k)

HYDROSIL; MAGIC; PERSONAL CATHETER

K-Number: K122785 · 2013-05-14

ApplicantRochester Medical Corp.
Decision Date2013-05-14
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYDROSIL; MAGIC; PERSONAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rochester Medical Corp.. It received FDA 510(k) clearance on 2013-05-14 under 510(k) number K122785. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROSIL; MAGIC; PERSONAL CATHETER?

HYDROSIL; MAGIC; PERSONAL CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-14. The listed applicant is Rochester Medical Corp.. The 510(k) number is K122785.

When did HYDROSIL; MAGIC; PERSONAL CATHETER receive FDA 510(k) clearance?

HYDROSIL; MAGIC; PERSONAL CATHETER received FDA 510(k) clearance on 2013-05-14, under 510(k) number K122785.

Who is the listed applicant for HYDROSIL; MAGIC; PERSONAL CATHETER?

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

What is the FDA product code for HYDROSIL; MAGIC; PERSONAL CATHETER?

The FDA product code for HYDROSIL; MAGIC; PERSONAL CATHETER is EZD.

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Other records listing Rochester Medical 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.

K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITK001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERK000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETERK971627SILICONE ANTIBACTERIAL FOLEY CATHETERK970704PERSONAL CATHETER

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Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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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