Forceps, Biopsy, Non-Electric, Reprocessed
The non-electric biopsy forceps (reprocessed) is a gastroenterological or urological device used to grasp and retrieve tissue samples through an endoscope for pathological examination. It is classified as FDA Class 1 under regulation 876.1075 in the Gastroenterology and Urology specialty, functioning equivalently to product code FCL but in reprocessed form. Reprocessing validation data must be included in the 510(k) submission for this device. Product code NON is eligible for third-party review.
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Basic Information
- Product Code
- NON
- Device Class
- FDA class 1
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
510(k) Clearance History
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 |
|---|---|---|---|---|
| K042648 | REPROCESSED COLD BIOPSY FORCEPS | Jul 20, 2005 | Substantially Equivalent | Sterilmed, Inc. |
| K042659 | MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS | Feb 14, 2005 | Substantially Equivalent | Medisiss |
| K042594 | VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS | Jan 25, 2005 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.