Product Code: FCC
FDA class 2
21 CFR 876.1500
Endoscopic Magnetic Retriever
Gastroenterology, Urology
The Endoscopic Magnetic Retriever (product code FCC) is a device passed through an endoscope and used to endoscopically retrieve magnetic foreign objects from the gastrointestinal or genitourinary tract. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
11
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Basic Information
- Product Code
- FCC
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
to endoscopically retrieve magnetic foreign objects
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904668 | IE MAGNETIC EXTRACTOR | Mar 21, 1991 | Substantially Equivalent | Olympus Corp. |
| K843135 | BRIMFIELD CANNULATED MAGNETIC RETRIEVER | Sep 26, 1984 | Substantially Equivalent | Brimfield Scientific Instruments |
| K800971 | M.R. ASSOC. MAGNETIC EXTRACTOR | May 08, 1980 | Substantially Equivalent | Mr Associates, Inc. |