Who is the manufacturer of OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE?

Opticon Medical, Inc. filed the 510(k) submission for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (K970716).

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

EZL. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE

K970716 · Opticon Medical, Inc. · EZL · May 16, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K970716
Device Name	OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
Applicant	Opticon Medical, Inc.
Product Code	EZL · Gastroenterology, Urology
Decision Date	May 16, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for male patients requiring continuous urinary drainage via urethral catheterization to pass fluids from the urinary bladder.

Regulatory Classification

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)

Related Devices

K961697 — OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE · Medical Device Intl., Inc. · Aug 30, 1996
K041983 — OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 · Opticon Medical · Nov 17, 2004
K024010 — DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER · The Kendall Company Div. of Tyco Healthcare Group · Jun 11, 2003
K161770 — Rusch Silicone Foley Catheter · Teleflexmedical, Inc. · May 5, 2017
K183335 — Medline Poly-Cath Red Polymer Urethral Catheter · Medline Industries, Inc. · Jun 12, 2019

Submission Summary (Full Text)

{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