Kollmann Urethral Dilator
FDA 510(k) K841386 · Imm Enterprises , Ltd.
510(k) numberK841386
Submission
- Device name
- Kollmann Urethral Dilator
- Applicant
- Imm Enterprises , Ltd.
Mchenry, IL, US - Received
- March 27, 1984
- Decision date
- May 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOE – Dilator, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation CatheterKOE · Traditional | Urotronic, Inc. | 01/02/2020SE |
| K032840 | Atrion Medical QL Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 03/03/2004SE |
| K972964 | Atrion Medical Balloon Catheter Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 10/10/1997SE |
| K962611 | Bard Eagle Inflation DeviceKOE · Traditional | Ryder Intl. Corp. | 10/21/1996SE |
| K961904 | Aq Hydrophilic DilatorsKOE · Traditional | Cook Urological, Inc. | 10/18/1996SE |
| K924440 | U.S. Medical PS-7000 Dialysis ScaleKOE · Traditional | U.S. Medical Corp. | 05/26/1993SE |
| K920551 | 120 FR Optilume Prostate Balloon DilatorKOE · Traditional | American Medical Systems, Inc. | 10/28/1992SE |
| K922349 | Dowd(Tm) IIKOE · Traditional | Boston Scientific Corp | 08/14/1992SE |
| K920711 | Entrac Urethral Balloon Dilatation CatheterKOE · Traditional | American Medical Systems, Inc. | 05/06/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | Peripheral Systems Group | 12/27/1991SE |
More from Peripheral Systems Group
| 510(k) | Device | Decision |
|---|---|---|
| K841387 | Weston Rectal SnareKOA · Traditional | 05/09/1984SE |
| K840311 | Cat. 7-EAR, Nose & Throat DevicesKCP · Traditional | 05/09/1984SE |
| K840304 | Category 17-MICROBIOLOGY DevicesHTD · Traditional | 05/01/1984SE |
| K840318 | Cat. 14-CLINICAL Toxiology DevicesHTD · Traditional | 04/23/1984SE |
| K840305 | Category 1 Circulatory System DeviceDWS · Traditional | 04/23/1984SE |
| K840312 | Cat. 8 Dental DevicesEMG · Traditional | 04/05/1984SE |
| K834171 | Op-Con Surg. Instrument #3KOA · Traditional | 04/04/1984SE |
| K834192 | Jakobi Surg. Instruments #3 21/22/24KOA · Traditional | 03/22/1984SE |
| K834191 | Jakobi Surgical Instruments #3 17/18/19KOA · Traditional | 03/22/1984SE |
| K840310 | Category 6 Opthalmic DevicesHOB · Traditional | 03/16/1984SE |
Questions and answers
When was Kollmann Urethral Dilator cleared by the FDA?
Kollmann Urethral Dilator (K841386) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 43 days after the submission was received.
What is the product code of K841386?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.