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FDA 510(k)

ALL SILICONE INTERMITTENT CATHETER

K-Number: K943851 · 1995-01-31

ApplicantRochester Medical Corp.
Decision Date1995-01-31
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL SILICONE INTERMITTENT 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 1995-01-31 under 510(k) number K943851. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL SILICONE INTERMITTENT CATHETER?

ALL SILICONE INTERMITTENT CATHETER is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Rochester Medical Corp.. The 510(k) number is K943851.

When did ALL SILICONE INTERMITTENT CATHETER receive FDA 510(k) clearance?

ALL SILICONE INTERMITTENT CATHETER received FDA 510(k) clearance on 1995-01-31, under 510(k) number K943851.

Who is the listed applicant for ALL SILICONE INTERMITTENT 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 ALL SILICONE INTERMITTENT CATHETER?

The FDA product code for ALL SILICONE INTERMITTENT CATHETER is GBM.

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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.

K122785HYDROSIL; MAGIC; PERSONAL CATHETERK033477HYDROPHILIC-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 CATHETER

View all 13 devices →

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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