Cleared Special

SPY Cystoscope/Hysteroscope

K252012 · Stryker Endoscopy · Obstetrics & Gynecology
Jul 2025
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K252012 is an FDA 510(k) clearance for the SPY Cystoscope/Hysteroscope, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on July 18, 2025, 21 days after receiving the submission on June 27, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K252012 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date July 18, 2025
Days to Decision 21 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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