Submission Details
| 510(k) Number | K021166 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2002 |
| Decision Date | May 09, 2002 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
May 2002
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K021166 is an FDA 510(k) clearance for the ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR, a Resectoscope, Working Element (Class II — Special Controls, product code FDC), submitted by Acmi-Circon Corporation (Southborough, US). The FDA issued a Cleared decision on May 9, 2002, 28 days after receiving the submission on April 11, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | FDC — Resectoscope, Working Element |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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