K913098 is an FDA 510(k) clearance for the APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 5, 1991, 116 days after receiving the submission on July 12, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K913098 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 1991 |
| Decision Date | November 05, 1991 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1075 |