# K970511: Dyonics Disposable Endoscopic Surgery Blades

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 12, 1997 after 182 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Stryker Endoscopy’s Curved Small Joint/ENT Disposable Blades: named in the summary without a submission number
- (no number) Linvatec Merlin Disposable Arthroscopic Surgery Blade: named in the summary without a submission number

## Most influential descendants
- K012536: Reprocessed Powered  Arthroscopic Accessories (2001), 1 descendant of its own
- K113028: Medisiss Reprocessed Arthroscopic Shavers and Burs (2011), 0 descendants of its own

## Indications for use
Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure. Contraindications: The 2.0mm and 2.9mm TurboWhisker® and 2.9mm Cutter are contraindicated for FESS applications.

Source page: https://510kreport.com/device/K970511
Methodology: https://510kreport.com/methodology