Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
The Reprocessed Endoscopic Electrosurgical Unit (with or without accessories) is a reprocessed gastroenterology/urology device intended to be used endoscopically to remove tissue and control bleeding using high-frequency electrical current; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLR and regulation 21 CFR 876.4300 in the Gastroenterology and Urology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NLR
- Device Class
- FDA class 2
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K030919 | SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES | Jul 03, 2003 | Substantially Equivalent | Medisiss |