K050136 is an FDA 510(k) clearance for the REPROCESSED HOT BIOPSY FORCEPS. This device is classified as a Forceps, Biopsy, Electric, Reprocessed (Class II - Special Controls, product code NLU).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 20, 2005, 180 days after receiving the submission on January 21, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300. The "forceps, Biopsy, Electric, Reprocessed" Are Intended To Be Used Endoscopically And Use Electric Current To (1) Obtain Tissue Samples For Histopathological Examination, (2) Allow For Coagulation So As To Prevent Bleeding, And (3) Destroy The Residuum Of The Lesion Being Biopsied. This Device Is Indicated For Reuse/reprocessing. 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 | K050136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2005 |
| Decision Date | July 20, 2005 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NLU — Forceps, Biopsy, Electric, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |
| Definition | The "forceps, Biopsy, Electric, Reprocessed" Are Intended To Be Used Endoscopically And Use Electric Current To (1) Obtain Tissue Samples For Histopathological Examination, (2) Allow For Coagulation So As To Prevent Bleeding, And (3) Destroy The Residuum Of The Lesion Being Biopsied. This Device Is Indicated For Reuse/reprocessing. 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). |