Submission Details
| 510(k) Number | K942450 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 1994 |
| Decision Date | August 05, 1994 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
ENDOPATH
Aug 1994
Decision
74d
Days
Class 1
Risk
About This 510(k) Submission
K942450 is an FDA 510(k) clearance for the ENDOPATH, a Catheter, Cholangiography (Class I — General Controls, product code GBZ), submitted by Ethicon Endo-Surgery, Inc. (Blue Ash, US). The FDA issued a Cleared decision on August 5, 1994, 74 days after receiving the submission on May 23, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
Device Classification
| Product Code | GBZ — Catheter, Cholangiography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |
Manufacturer
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