GM501 Wash
510(k) K190383
GM501 Wash is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Hamilton Thorne, Inc, cleared under FDA 510(k) K190383 on 5 Sep 2019, active as of 8 Nov 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 | NumberK190383 | Date5 Sep 2019 | StatusActive |
Official records
- FDA 510(k) database K190383
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- FDA applicant
- Hamilton Thorne, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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