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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2025-07-18 under 510(k) 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. The listed applicant is Stryker Endoscopy. The 510(k) number is K252012.

When did SPY Cystoscope/Hysteroscope receive FDA 510(k) clearance?

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

Who is the listed applicant for SPY Cystoscope/Hysteroscope?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyNOT_YET_RECRUITING

Other records listing Stryker Endoscopy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownK253602Precision S 4K SinuscopeK261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemK2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityK260108L12 LED Light Source with AIMK254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

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Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K243382RZ Resectoscope SystemRz Medizintechnik GmbHK240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)MacroLux Medical Technology Co., Ltd.

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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