KOE · Dilator, Urethral
Gastroenterology, Urology · 21 CFR 876.5520 · Class 2
Overview
| Product Code | KOE |
|---|---|
| Device Name | Dilator, Urethral |
| Regulation | 21 CFR 876.5520 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.
Classification Rationale
(1) Class II (special controls). Except when it is a mechanical urethral dilator, 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.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* (1) Class II (special controls). Except when it is a mechanical urethral dilator, 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.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | Jan 2, 2020 | SESE |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | Atrion Medical Products, Inc. | Mar 3, 2004 | SESE |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | Atrion Medical Products, Inc. | Oct 10, 1997 | SESE |
| K962611 | BARD EAGLE INFLATION DEVICE | Ryder Intl. Corp. | Oct 21, 1996 | SESE |
| K961904 | AQ HYDROPHILIC DILATORS | Cook Urological, Inc. | Oct 18, 1996 | SESE |
| K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE | U.S. Medical Corp. | May 26, 1993 | SESE |
| K920551 | 120 FR OPTILUME PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | Oct 28, 1992 | SESE |
| K922349 | DOWD(TM) II | Boston Scientific Corp | Aug 14, 1992 | SESE |
| K920711 | ENTRAC URETHRAL BALLOON DILATATION CATHETER | American Medical Systems, Inc. | May 6, 1992 | SESE |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | Peripheral Systems Group | Dec 27, 1991 | SESE |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | Advanced Surgical Intervention, Inc. | Aug 27, 1990 | SESE |
| K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | Advanced Surgical Intervention, Inc. | May 24, 1990 | SESE |
| K900761 | AMS OPTILUME(TM) PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | May 17, 1990 | SESE |
| K900760 | AMS OPTILUME INFLATION SYRINGE | American Medical Systems, Inc. | May 17, 1990 | SESE |
| K892855 | URETHRAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | Nov 17, 1989 | SESE |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | Medi-Tech, Inc. | Jul 31, 1989 | SESE |
| K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | Penn Medical Devices, Inc. | Oct 14, 1987 | SESE |
| K870695 | VAN-TEC URETHRAL DILATATION SYSTEM | Van-Tec, Inc. | Mar 10, 1987 | SESE |
| K851158 | VAN-TEC MEATAL DILATOR | Van-Tec, Inc. | Apr 15, 1985 | SESE |
| K841386 | KOLLMANN URETHRAL DILATOR | Imm Enterprises , Ltd. | May 9, 1984 | SESE |
Top Applicants
- American Medical Systems, Inc. — 4 clearances
- Vance Products, Inc. — 4 clearances
- Advanced Surgical Intervention, Inc. — 2 clearances
- Atrion Medical Products, Inc. — 2 clearances
- Cook Urological, Inc. — 2 clearances
