# K922391: Endoscopic Carpal Tunnel Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Aug 18, 1992 after 90 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K072684: Mondeal Endoscopic Tissue Recession and Release System (2008), 0 descendants of its own

## Recalls of this device
- Apr 30, 2019 · Class II · Z-1849-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Apr 30, 2019 · Class II · Z-1848-2019: The seal integrity of the sterile bag containing the kits may be compromised.

Source page: https://510kreport.com/device/K922391
Methodology: https://510kreport.com/methodology