Msi Bipolar Sheath
by Medical Scientific, Inc. 510(k)
Active
510(k) K011202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011202 | Date31 Dec 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Msi Bipolar Sheath is an arthroscope designed for use in orthopedic procedures. It functions as a specialized instrument within the field of arthroscopy.
This device is identified by FDA 510(k) number K011202 and is classified under product code HRX. It received FDA 510(k) clearance on December 31, 2001, following a traditional review process.
Other devices from Medical Scientific, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the primary clinical use of the MSI Bipolar Sheath?
The MSI Bipolar Sheath is an arthroscope specifically designed to function as an instrument during orthopedic surgical procedures.
What is the regulatory status of this device?
The MSI Bipolar Sheath received FDA 510(k) clearance on December 31, 2001, under the submission number K011202. It is classified under product code HRX.
Which advisory committee oversaw the review of this device?
The device was reviewed by the Orthopedic advisory committee, which is responsible for evaluating instruments used in orthopedic surgery.