# K974767: Smith & Nephew Dyonics Arthoscopes/Endoscopes, Smith & Nephew Dyonics Laparoscopes, Snith & Nephew Dyonics Hysteroscopes

- Pathway: 510(k) (Traditional)
- Applicant: Endoscopy Division
- Decided: Jan 23, 1998 after 32 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) Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes: named in the summary without a submission number

## Indications for use
The Dyonics® line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate. Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site. The Smm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels. Dyonics Hysterosocpes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The abrasive cleaning agent is provided as an accessory to the Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes and is intended to be used, when required, to remove deposits on optical surfaces thus maintaining optical integrity and allowing the scopes to perform as per their intended uses.

Source page: https://510kreport.com/device/K974767
Methodology: https://510kreport.com/methodology