Rapid Automatic Pneumoperitoneum-I
by Trek Medical Products, Inc.
510(k) K900808
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900808 | Date19 Sep 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Rapid Automatic Pneumoperitoneum-I is a Laparoscopic Insufflator, a medical device designed to introduce carbon dioxide gas into the abdominal cavity during laparoscopic procedures. It facilitates insufflation by creating and maintaining pneumoperitoneum, which provides the necessary working space for surgical instruments and visualization tools.
This device is intended for use in operating rooms and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the product code HIF and regulation number 884.1730, classified under FDA Class II. The device is associated with the Obstetrics/Gynecology specialty and was reviewed by the Obstetrics Advisory Committee. No specific sterility or MRI safety information is provided in the available data.