Clearance Summary
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device received FDA 510(k) clearance under submission number K242976, sponsored by Medical Wire & Equipment Company (Bath), Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-11-26.
- Submission: K242976
- Applicant / Sponsor: Medical Wire & Equipment Company (Bath), Ltd.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.2390
- Decision date: 2025-11-26
Classification & Regulation
This clearance is catalogued under FDA product code JSM and 21 CFR 866.2390, within the Microbiology review panel as a Class I device.