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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2022-06-17 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K221217.

When did SPY Laparoscope receive FDA 510(k) clearance?

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

Who is the listed applicant for SPY Laparoscope?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

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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