K970788 is an FDA 510(k) clearance for the PNEUMO-MATIC INSUFFLATION NEEDLE, a Pneumoperitoneum Needle (Class II — Special Controls, product code FHO), submitted by Apple Medical Corp. (Bolton, US). The FDA issued a Cleared decision on March 27, 1997, 23 days after receiving the submission on March 4, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K970788 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 1997 |
| Decision Date | March 27, 1997 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FHO — Pneumoperitoneum Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | For Establishment Of A Pneumoperitoneum In Abdomen. |