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FDA 510(k)

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE

K-Number: K970716 · 1997-05-16

ApplicantOpticon Medical, Inc.
Decision Date1997-05-16
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Opticon Medical, Inc.. It received FDA 510(k) clearance on 1997-05-16 under 510(k) number K970716. 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 OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE?

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Opticon Medical, Inc.. The 510(k) number is K970716.

When did OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE receive FDA 510(k) clearance?

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE received FDA 510(k) clearance on 1997-05-16, under 510(k) number K970716.

Who is the listed applicant for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE?

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

What is the FDA product code for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE?

The FDA product code for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE is EZL.

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Other records listing Opticon Medical, 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.

K033830OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000K023090OPTION-VF URINARY CATHETER, FV14218K930194HEMOSTASIS VALVE AND TUBING SETK904999WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTEK895955LOPER CELIAC PLEXUS BLOCK CATHETER KITK895476OPTION EPIDURAL CATHETERS

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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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