# K221217: SPY Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jun 17, 2022 after 51 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
Longest line of descent: 20 generations back to K930667 (1994). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210088: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes, Stryker (2021) Summary page 4.

## Most influential descendants
- K252010: SPY Laparoscope (2025), 0 descendants of its own

## Indications for use
The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.

Source page: https://510kreport.com/device/K221217
Methodology: https://510kreport.com/methodology