EXJ · Device, Incontinence, Urosheath Type, Sterile
Gastroenterology, Urology · 21 CFR 876.5250 · Class 1
Overview
| Product Code | EXJ |
|---|---|
| Device Name | Device, Incontinence, Urosheath Type, Sterile |
| Regulation | 21 CFR 876.5250 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and (2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
Classification Rationale
(1) Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Special Controls
*Classification* —(1)*Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter.* The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) *Class I (general controls).* For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970465 | BOUSER'S URINAL | General Polymers | Dec 18, 1997 | SESE |
| K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | Advanced Care Medical Products | Jul 31, 1997 | SESE |
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | Apr 22, 1997 | SESE |
| K963265 | PROSYS SAMEC LA | Convatec, A Division of E.R. Squibb & Sons | Oct 25, 1996 | SESE |
| K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER | Hollister, Inc. | Sep 16, 1996 | SESE |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | Jul 15, 1996 | SESE |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | Jul 15, 1996 | SESE |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | Rochester Medical Corp. | Jul 18, 1995 | SESE |
| K945628 | CLEAR ADVANTAGE II | Mentor Corp. | Jul 6, 1995 | SESE |
| K951530 | PROSYS URIHESIVE SYSTEM LA | Convatec, A Division of E.R. Squibb & Sons | May 12, 1995 | SESE |
| K950690 | PROSYS URIHESICE SYSTEM NL | Convatec, A Division of E.R. Squibb & Sons | Mar 23, 1995 | SESE |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Convatec, A Bristol-Myers Squibb Co. | Mar 17, 1995 | SESE |
| K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER | Coloplast A/S | Feb 13, 1995 | SESE |
| K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER | Hollister, Inc. | Jun 2, 1994 | SESE |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | Apr 19, 1994 | SESE |
| K931156 | CONE CATH | Sierra Laboratories, Inc. | Jul 1, 1993 | SESE |
| K923136 | MALE EXTERNAL CATHETER | Rochester Medical Corp. | Dec 3, 1992 | SESE |
| K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH | Coloplast A/S | Sep 23, 1992 | SESE |
| K913524 | SILICONE MALE EXTERNAL CATHETER | Mentor Corp. | Oct 4, 1991 | SESE |
| K903715 | CONDOM SEAL | Mark Sullivan, M.D., P.C. | Jan 23, 1991 | SESE |
Top Applicants
- Sierra Laboratories, Inc. — 5 clearances
- Convatec, A Division of E.R. Squibb & Sons — 3 clearances
- Coloplast A/S — 2 clearances
- Hollister, Inc. — 2 clearances
- Mentor Corp. — 2 clearances
