# K971781: Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Greatbatch Technologies, Inc.
- Decided: Nov 21, 1997 after 191 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Optus Arthroscopes and Mini Arthroscopes: named in the summary without a submission number

## Indications for use
The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal-mandibular joint of patients in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

Source page: https://510kreport.com/device/K971781
Methodology: https://510kreport.com/methodology