Neuroview Instrument Holder, Model 300-33
by Integra Neurocare, LLC 510(k)
Active
510(k) K992006
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992006 | Date17 Aug 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- OCV
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Neuroview Instrument Holder, Model 300-33 is an endoscope holder classified under product code OCV and regulation number 876.1500. It is a reusable, stainless steel mechanical accessory designed for use in operating rooms. The device consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp, and is table-mounted to allow surgeons to position and lock a neuro navigational endoscope over a patient.
It is supplied as a reusable device and has received FDA 510(k) clearance under K992006, with a decision date of August 17, 1999. The device is classified as Class II with special controls and is intended for use in gastroenterology and urology settings. No information regarding sterility, MRI safety, specific sizes, or storage conditions is provided in the data.
Other devices from Integra Neurocare, LLC
Questions
AI-generated answers, 27 Sep 2026
What is the Neuroview Instrument Holder, Model 300-33 used for?
It is designed to position and lock a neuro navigational endoscope over a patient during procedures, allowing surgeons to stabilize the scope in operating rooms for gastroenterology and urology applications.
Is the Neuroview Instrument Holder, Model 300-33 reusable or single-use?
The device is supplied as a reusable instrument holder made of stainless steel, meaning it can be cleaned and reused multiple times following appropriate reprocessing protocols.
What components make up the Neuroview Instrument Holder, Model 300-33?
It consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp, which together enable secure table-mounted positioning of an endoscope.
What regulatory pathway was used for the Neuroview Instrument Holder, Model 300-33?
The device received FDA 510(k) clearance under submission K992006, with a decision date of August 17, 1999, and is classified as a Class II medical device with special controls.