K100273 is an FDA 510(k) clearance for the INSTAFLO BOWEL CATHETER SYSTEM KIT. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on April 22, 2010, 83 days after receiving the submission on January 29, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K100273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | January 29, 2010 |
| Decision Date | April 22, 2010 |
| Days to Decision | 83 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |