# K971375: Greatbatch Scientific MR Compatible Sinuscope

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Greatbatch Technologies, Inc.
- Decided: Oct 31, 1997 after 200 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 Sinuscope and Accessories: named in the summary without a submission number

## Indications for use
The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

Source page: https://510kreport.com/device/K971375
Methodology: https://510kreport.com/methodology