NGR · Tester, Stiffness, Cartilage, Arthroscopic
Orthopedic · 21 CFR 888.1100 · Class 2
Overview
| Product Code | NGR |
|---|---|
| Device Name | Tester, Stiffness, Cartilage, Arthroscopic |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 3rd-Party Reviewable | Yes |
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013429 | ACTAEON PROBE | Osteobiologics, Inc. | Jan 11, 2002 | SESE |
| K010303 | ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE | Artscan Medical Innovations | Sep 11, 2001 | SESE |
Top Applicants
- Osteobiologics, Inc. — 1 clearance
- Artscan Medical Innovations — 1 clearance
