Nuvis Arthroscope
510(k) K140903
Nuvis Arthroscope is a Class II device made by Integrated Endoscopy, Inc., cleared under FDA 510(k) K140903 on 17 Jul 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140903 | Date17 Jul 2014 | StatusActive |
Official records
- FDA 510(k) database K140903
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
From the manufacturer
Manufacturer's product page: Download Nuvis IFU English
Devices cleared under K140903
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Nuvis 140-4010-1 | 140-4010-1 / 140-4010-1 | 08538160080010 | Angle 30 deg; Outer Diameter 4 mm; Length 140 mm | No longer on the market |
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Other devices filed under FDA product code HRX (Arthroscope).
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- Pegasus System by A.M. SURGICAL, INC.
- NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER by Surgical Dynamics, Inc.