HSG TRAY— 510(k) K920803

Unknown

Unimar, Inc.

FDA 510(k) clearance K920803 for HSG TRAY, Unknown on 1992-10-19. Applicant: Unimar, Inc.. Device class: 2.

Clearance details

Applicant: Unimar, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1992-02-21
Decision date: 1992-10-19
Decision: Unknown
Clearance type: Traditional
Location: Wilton, CT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K920803

K-number listed on FDA's recall record

Z-2135-2025 — HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.Class II·Ongoing·CooperSurgical, Inc.·20250611
Z-2136-2025 — Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitClass II·Ongoing·CooperSurgical, Inc.·20250611
Z-2137-2025 — Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.Class II·Ongoing·CooperSurgical, Inc.·20250611

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K920803.

Data sourced from openFDA. This site is unofficial and independent of the FDA.