# K970949: Smith & Nephew Mis Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Apr 23, 1997 after 40 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) Karl Storz Take-Apart Endoscopic Instruments: named in the summary without a submission number
- (no number) Richard Wolf Laparoscopic Instruments: named in the summary without a submission number

## Indications for use
The Smith & Nephew MIS Instruments are indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures.

Source page: https://510kreport.com/device/K970949
Methodology: https://510kreport.com/methodology