K094009 is an FDA 510(k) clearance for the HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI).
Submitted by Halt Medical, Inc. (Brentwood, US). The FDA issued a Cleared decision on June 14, 2010, 168 days after receiving the submission on December 28, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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 | K094009 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2009 |
| Decision Date | June 14, 2010 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEI — Electrosurgical, Cutting & Coagulation & Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| 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). |