Gastric Lavage Kit
by Autovage
510(k) K823195
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823195 | Date3 Dec 1982 | 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- Withdrawn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
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Gastric Lavage Kit is a medical device classified as a gastric lavage system (product code KNT), designed for the irrigation and evacuation of stomach contents. It consists of semi-rigid tubing and components to facilitate controlled lavage, reducing exposure risk for healthcare providers during procedures such as decontamination or emergency gastric emptying. The closed-system design minimizes contamination while enabling rapid fluid exchange. This device is intended for use in acute gastrointestinal emergencies, including poisoning or gastric dilatation volvulus.
The kit is supplied as a disposable, single-use assembly and requires no sterilization. It is intended for use in clinical settings, such as emergency departments or critical care units, where immediate gastric evacuation is necessary. The semi-rigid tubing and large-bore components ensure compatibility with standard medical suction systems. Regulatory clearance was granted under FDA 510(k) K823195 in 1982, with the device classified under the Gastroenterology, Urology advisory committee. No MRI safety or reusable specifications are indicated.