# K970247: Smith & Nephew Images Arthroscope/Ent Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 21, 1997 after 58 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) Sinuscopes: named in the summary without a submission number
- (no number) Video components: named in the summary without a submission number
- (no number) Surgical cameras: named in the summary without a submission number
- (no number) Illuminators: named in the summary without a submission number
- (no number) Accessories: named in the summary without a submission number
- (no number) ENT surgical hand instruments: named in the summary without a submission number

## Indications for use
Smith & Nephew Images Endoscopic Video System and components are indicated for use in diagnostic and operative arthroscopic, laparoscopic and ENT endoscopic procedures to provide illumination and allow visualization of the surgical site. Smith & Nephew Manual Surgical Instruments for Sinus Surgery are indicated for the endoscopic examination and treatment of the nasal cavity and nasal pharynx.

Source page: https://510kreport.com/device/K970247
Methodology: https://510kreport.com/methodology