Sterile Water
510(k) K943773
Sterile Water is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K943773 on 27 Feb 1995, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943773 | Date27 Feb 1995 | StatusActive |
Official records
- FDA 510(k) database K943773
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOL
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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- STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION by Welcon, Inc.
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- DISPOSABLE SUCTION PROBE by United States Surgical, A Division of Tyco Healthc