K182024 is an FDA 510(k) clearance for the Dissecting Balloon System. This device is classified as a Laparoscope, General & Plastic Surgery (Class II - Special Controls, product code GCJ).
Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on August 30, 2018, 31 days after receiving the submission on July 30, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K182024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2018 |
| Decision Date | August 30, 2018 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCJ — Laparoscope, General & Plastic Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |