# K972280: Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Wilson Greatbatch Technologies, Inc.
- Decided: Dec 11, 1997 after 176 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 Laparoscope and Operating Laparoscope: named in the summary without a submission number

## Indications for use
The Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes are used to permit viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

Source page: https://510kreport.com/device/K972280
Methodology: https://510kreport.com/methodology