# K993688: Aed Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: National Advanced Endoscopy Devices, Inc.
- Decided: Dec 6, 1999 after 35 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031141: Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope (2003), 21 descendants of its own
- K060899: Flexilux II Cystoscope and Hysteroscope (2007), 19 descendants of its own
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), 18 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own

## Indications for use
This device is used to provide visual information about the condition of the interior of the pelvic cavity, and visualization of the interior of the abdominal cavity or areas subject to general or plastic surgery for diagnostic and surgical procedures. This device provides information for diagnosis and/or surgical access with only a small incision. The AED line of rigid Laparoscopes is indicated to provide illumination and visualization in: « Diagnostic and operative laparoscopic procedures.

Source page: https://510kreport.com/device/K993688
Methodology: https://510kreport.com/methodology