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Insufflator
Scivita Medical Technology Co., Ltd. · Model SL102 · UDI-DI 06971381251364
HIF
Prescription
1
510(k) clearances
7,600
Adverse events (34 deaths)
29
Recalls
141
Facilities
Description
The product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-16 | Olympus Corporation of the Americas | Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
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