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FDA 510(k)

SPY Cystoscope/Hysteroscope

K-Number: K252012 · 2025-07-18

ApplicantStryker Endoscopy
Decision Date2025-07-18
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 2025-07-18 under approval number K252012. 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 2025-07-18. It is manufactured by Stryker Endoscopy. The 510(k) number is K252012.

When was SPY Cystoscope/Hysteroscope approved by the FDA?

SPY Cystoscope/Hysteroscope received FDA 510(k) clearance on 2025-07-18, under approval number K252012.

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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K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.

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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