# K971374: Greatbatch Scientific MR Compatible Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Greatbatch Technologies, Inc.
- Decided: May 13, 1998 after 394 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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, Inc. Hysteroscopes and Accessories: named in the summary without a submission number

## Indications for use
The Greatbatch Scientific MR Compatible Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K971374
Methodology: https://510kreport.com/methodology