Cleared Special

SPY Laparoscope

K252010 · Stryker Endoscopy · General & Plastic Surgery

Jul 2025

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K252010 is an FDA 510(k) clearance for the SPY Laparoscope, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on July 24, 2025, 27 days after receiving the submission on June 27, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K252010 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2025
Decision Date	July 24, 2025
Days to Decision	27 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).