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FDA 510(k)

SPY Laparoscope

K-Number: K221217 · 2022-06-17

ApplicantStryker
Decision Date2022-06-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPY Laparoscope is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2022-06-17 under approval number K221217. 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 2022-06-17. It is manufactured by Stryker. The 510(k) number is K221217.

When was SPY Laparoscope approved by the FDA?

SPY Laparoscope received FDA 510(k) clearance on 2022-06-17, under approval number K221217.

What company makes SPY Laparoscope?

SPY Laparoscope is manufactured by Stryker.

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.

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