K042648 is an FDA 510(k) clearance for the REPROCESSED COLD BIOPSY FORCEPS. This device is classified as a Forceps, Biopsy, Non-electric, Reprocessed (Class I - General Controls, product code NON).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 20, 2005, 295 days after receiving the submission on September 28, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075. Same As Procode Fcl Except This Product Is For The Reprocessed Device. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K042648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2004 |
| Decision Date | July 20, 2005 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NON — Forceps, Biopsy, Non-electric, Reprocessed |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1075 |
| Definition | Same As Procode Fcl Except This Product Is For The Reprocessed Device. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |