# K252010: SPY Laparoscope

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Jul 24, 2025 after 27 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: 21 generations back to K930667 (1994). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221217: SPY Laparoscope, Stryker (2022) Summary page 5.
- K910132: Stryker Laparoscope, Stryker Corp. (1991) Summary page 5.

## 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/K252010
Methodology: https://510kreport.com/methodology