# K141515: Aed Hysteroscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: National Advanced Endoscopy Devices, Inc.
- Decided: Jan 7, 2015 after 212 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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 K935716 (1995). 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)
- K935716: Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 4.

## Indications for use
AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K141515
Methodology: https://510kreport.com/methodology