← Product Code [EZL](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL) · K970716 # OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (K970716) _Opticon Medical, Inc. · EZL · May 16, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL/K970716 ## Device Facts - **Applicant:** Opticon Medical, Inc. - **Product Code:** [EZL](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL.md) - **Decision Date:** May 16, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5130 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags. ## Device Story Sterile, single-use, flexible silicone tubular catheter; inserted through male urethra to facilitate continuous urine drainage from bladder. Requires external introducer (e.g., Bard 0420 Wire Stylet) for insertion; connects to standard drainage tubes, adaptors, and bags. Used in clinical settings by healthcare professionals. Provides passive drainage path; aids patient management of urinary retention or incontinence. ## Clinical Evidence Bench testing only. Device tested to ASTM Standard F623-89, 'Standard Performance Specification for Foley Catheter'; met all performance requirements. ## Technological Characteristics Material: soft biocompatible silicone. Form factor: flexible tubular catheter. Energy source: none (passive). Connectivity: mechanical connection to standard drainage systems. Sterilization: sterile, single-use. ## Regulatory Identification A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use). ## Predicate Devices - OPTICON™ Direct Female Urinary Catheter for Continuous Drainage ([K961697](/device/K961697.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970716 MAY 16 1997 510(k) Summary SUBMITTER: OPTICON™ Medical Inc. Address: 14505 21st Avenue North, Suite 216 Plymouth, MN 55447 Telephone: 612-404-0113 CONTACT PERSON: Greg Sachs 612-404-0113 DATE SUMMARY PREPARED: February 26, 1997 TRADE NAME: OPTICON™ Direct Male Urinary Catheter for Continuous Drainage COMMON NAME: Foley Catheter CLASSIFICATION NAME: Urological Catheter SUBSTANTIALLY EQUIVALENT TO: The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is substantially equivalent to the OPTICON™ Direct Female Urinary Catheter for Continuous Drainage (K961697). DESCRIPTION of the DEVICE: The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular catheter that is inserted through the urethra to pass urine from the urinary bladder, when connected to standard drainage tubes, drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone. The male catheter requires an introducer for insertion. OPTICON™ Medical currently recommends the use of a commonly available introducer, (such as the Bard 0420 Wire Stylet) to aid in insertion. This introducer is not sold by OPTICON™ Medical, nor is the introducer included in the packaging for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage Catheter. The catheter is to be used only with standard urinary drainage tubes, drainage tube adaptors, tubes and bags. INDICATIONS for USE: The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags. CLINICAL INFORMATION and SAFETY and EFFECTIVENESS: The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage has been tested to the ASTM Standard F623-89, "Standard Performance Specification for Foley Catheter" and was found to meet all performance requirements. 16 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL/K970716](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZL/K970716) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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