Submission Details
| 510(k) Number | K841386 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 1984 |
| Decision Date | May 09, 1984 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
K841386 - KOLLMANN URETHRAL DILATOR
(FDA 510(k) Clearance)
May 1984
Decision
43d
Days
Class 2
Risk
K841386 is an FDA 510(k) clearance for the KOLLMANN URETHRAL DILATOR. This device is classified as a Dilator, Urethral (Class II — Special Controls, product code KOE).
Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984, 43 days after receiving the submission on March 27, 1984.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
Device Classification
| Product Code | KOE — Dilator, Urethral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5520 |
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