Who is the manufacturer of OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE?

Medical Device Intl., Inc. filed the 510(k) submission for OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE (K961697).

What is the FDA product code for OPTICON FEMALE URINARY INCONTINENCE 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 FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE?

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

What are the predicate devices for OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE?

Bardex Silicone Foley Catheter (K760093); Rochester Medical Female Uretheral Catheter (K941692).

Who can help prepare an FDA 510(k) submission like OPTICON FEMALE URINARY INCONTINENCE 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 FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE

K961697 · Medical Device Intl., Inc. · EZL · Aug 30, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K961697
Device Name	OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
Applicant	Medical Device Intl., Inc.
Product Code	EZL · Gastroenterology, Urology
Decision Date	Aug 30, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The OPTICON™ Female 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, tubular silicone catheter; 18 French size; 10.8 cm length. Inserted through urethra for continuous bladder drainage. Features microvalve for balloon inflation and retainer ring. Used in clinical settings by healthcare professionals. Connects to standard drainage tube adaptors, tubes, and bags. Facilitates urine passage from urinary tract; 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', meeting all performance requirements.

Technological Characteristics

Material: Biocompatible silicone. Dimensions: 18 French, 10.8 cm length. Design: Tubular, single-use, balloon-retained. Standards: ASTM F623-89. Sterilization: Sterile.

Indications for Use

Indicated for female patients requiring continuous urinary drainage 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

Bardex Silicone Foley Catheter (K760093)
Rochester Medical Female Uretheral Catheter (K941692)

Related Devices

K041983 — OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 · Opticon Medical · Nov 17, 2004
K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE · Opticon Medical, Inc. · May 16, 1997
K173340 — Yikang Latex Foley Catheter · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Jul 13, 2018
K161770 — Rusch Silicone Foley Catheter · Teleflexmedical, Inc. · May 5, 2017
K970704 — PERSONAL CATHETER · Rochester Medical Corp. · Mar 13, 1997

Submission Summary (Full Text)

{0} AUG 30 1996 K961697 # 510(k) Summary SUBMITTER: Medical Device International, Inc. Address: 5116 Birch Road Minnetonka, MN 55345 Telephone: 612-938-4125 CONTACT PERSON: Greg Sachs 612-938-4125 DATE SUMMARY PREPARED: April 30, 1996 TRADE NAME: OPTICON™ Female Urinary Catheter for Continuous Drainage COMMON NAME: Foley Catheter CLASSIFICATION NAME: Urological Catheter SUBSTANTIALLY EQUIVALENT TO: The OPTICON™ Female Urinary Catheter for Continuous Drainage is substantially equivalent to the Bardex Silicone Foley Catheter (K760093) and the Rochester Medical Female Uretheral Catheter (K941692). DESCRIPTION of the DEVICE: The OPTICON™ Female Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular device that is inserted through the urethra and is used to pass urine from the urinary tract when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone and comes in only one size (18 French) and length, 10.8 cm (4.3 inches). When inserted, all that is visible outside of the body is a microvalve for balloon inflation and retainer ring. The device is to be used only with standard urinary drainage tube adaptors, tubes and bags. INDICATIONS for USE: The OPTICON™ Female 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™ Female 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. 5knum86.doc