# K971676: Limited Reuse Endoscopic Blades

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 27, 1997 after 51 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
Longest line of descent: 1 generation back to K955914 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955914: Limited Reuse Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1996) Summary page 1.

## Indications for use
The Smith & Nephew, Inc., Endoscopy Division Limited Reuse Endoscopic Surgery Blades as indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the blade by healthcare facilities.

Source page: https://510kreport.com/device/K971676
Methodology: https://510kreport.com/methodology