SPY Laparoscope
K-Number: K252010 · 2025-07-24
ApplicantStryker Endoscopy
Decision Date2025-07-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SPY Laparoscope is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2025-07-24 under approval number K252010. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SPY Laparoscope?
SPY Laparoscope is a medical device that received FDA 510(k) clearance on 2025-07-24. It is manufactured by Stryker Endoscopy. The 510(k) number is K252010.
When was SPY Laparoscope approved by the FDA?
SPY Laparoscope received FDA 510(k) clearance on 2025-07-24, under approval number K252010.
What company makes SPY Laparoscope?
SPY Laparoscope is manufactured by Stryker Endoscopy.
What is the FDA product code for SPY Laparoscope?
The FDA product code for SPY Laparoscope is GCJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.