# K940230: Endoscopic Mortons Neuroma Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Dec 12, 1994 after 332 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 13 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jul 25, 2019 · Class II · Z-2421-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2420-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2419-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2415-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2416-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2413-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2414-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2422-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2412-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2418-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2417-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2423-2019: The seal integrity of the sterile bag containing the kits may be compromised.
- Jul 25, 2019 · Class II · Z-2424-2019: The seal integrity of the sterile bag containing the kits may be compromised.

Source page: https://510kreport.com/device/K940230
Methodology: https://510kreport.com/methodology