K944418 is an FDA 510(k) clearance for the THE SPACEMAKER AND THE SPACEMAKER II. This device is classified as a Laparoscope, General & Plastic Surgery (Class II - Special Controls, product code GCJ).
Submitted by General Surgical Innovations (Palo Alto, US). The FDA issued a Cleared decision on November 1, 1994, 54 days after receiving the submission on September 8, 1994.
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 | K944418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1994 |
| Decision Date | November 01, 1994 |
| Days to Decision | 54 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). |