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FDA 510(k)

SPY Cystoscope/Hysteroscope

K-Number: K233635 · 2024-02-12

ApplicantStryker Endoscopy
Decision Date2024-02-12
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPY Cystoscope/Hysteroscope is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2024-02-12 under approval number K233635. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPY Cystoscope/Hysteroscope?

SPY Cystoscope/Hysteroscope is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Stryker Endoscopy. The 510(k) number is K233635.

When was SPY Cystoscope/Hysteroscope approved by the FDA?

SPY Cystoscope/Hysteroscope received FDA 510(k) clearance on 2024-02-12, under approval number K233635.

What company makes SPY Cystoscope/Hysteroscope?

SPY Cystoscope/Hysteroscope is manufactured by Stryker Endoscopy.

What is the FDA product code for SPY Cystoscope/Hysteroscope?

The FDA product code for SPY Cystoscope/Hysteroscope is HIH.

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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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