BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
FDA 510(k) clearance K984168 · decided 1999-12-07
Clearance details
- K-number
- K984168
- Device name
- BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-20
- Decision date
- 1999-12-07
- Days to decision
- 382 days
- Clearance type
- Traditional
- Product code
- FCF
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM (K070759) | Vidacare Corporation | 2007-05-21 |
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| AMCATH DISPOSABLE BIOPSY FORCEPS (K915142) | Intl. Medical, Inc. | 1992-01-10 |
| OVAL CUP BIOPSY FORCEP (K911155) | Endovations | 1991-08-07 |
| PHARMA-PLAST RECTAL TIP (K843477) | Zimmar Consulting , Ltd. | 1984-12-05 |
Recalls involving this device
No recalls on record reference this clearance.