K182828 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer. This device is classified as a Laparoscope, General & Plastic Surgery, Reprocessed (Class II - Special Controls, product code NLM).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on April 15, 2019, 192 days after receiving the submission on October 5, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. 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 | K182828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2018 |
| Decision Date | April 15, 2019 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NLM — Laparoscope, General & Plastic Surgery, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. 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). |