Product Code: FCI
FDA class 2
21 CFR 876.1075
Punch, Biopsy
Gastroenterology, Urology
The Biopsy Punch (product code FCI) is a circular cutting instrument used to excise small cylindrical tissue specimens from the gastrointestinal or genitourinary tract for histological examination. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
7
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Basic Information
- Product Code
- FCI
- Device Class
- FDA class 2
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K895885 | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING | Feb 09, 1990 | Substantially Equivalent | National-Standard Co. |
| K894627 | BT-338N ELECTRONIC CLINICAL THERMOMETER | Oct 23, 1989 | Substantially Equivalent | Integrated Display Technology, Ltd. |
| K875119 | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | Mar 02, 1988 | Substantially Equivalent | Advanced Diagnostic Medical Systems, Inc. |
| K853104 | DISPOSABLE, STERILE BIOPSY PUNCH | Oct 04, 1985 | Substantially Equivalent | August C. Stiefel Research Institute, Inc. |
| K831317 | BIOPSY ATTACHMENT | May 18, 1983 | Substantially Equivalent | Diasonics, Inc. |