Barrett's Esophageal Cytology Device
FDA 510(k) K984168 · United States Endoscopy Group, Inc.
510(k) numberK984168
Submission
- Device name
- Barrett's Esophageal Cytology Device
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- November 20, 1998
- Decision date
- December 7, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCF – Instrument, Biopsy, Mechanical, Gastrointestinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Barrett's Esophageal Cytology Device cleared by the FDA?
Barrett's Esophageal Cytology Device (K984168) received a 510(k) decision of Substantially Equivalent on December 7, 1999, 382 days after the submission was received.
What is the product code of K984168?
The FDA product code is FCF – Instrument, Biopsy, Mechanical, Gastrointestinal, a Class II (moderate risk) device regulated under 21 CFR 876.1075.