Home › KEY SURGICAL, INC. › Key Surgical Mr. Clear Anti-Fog
Key Surgical Mr. Clear Anti-Fog
KEY SURGICAL, INC. · Model AF-031 · UDI-DI 00849771037859
OCT
Prescription
1
510(k) clearances
182
Adverse events
2
Recalls
62
Facilities
Description
Key Surgical Mr. Clear Anti-Fog is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-14 | Sunstar Americas, Inc. | Product lacks premarket clearance. |
| 2019-05-30 | Medline Industries, Inc. | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
