Cleared Traditional

CONTROL SYRINGE

K972655 · Medical Specialties Intl., Inc. · Radiology
Nov 1997
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K972655 is an FDA 510(k) clearance for the CONTROL SYRINGE, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Medical Specialties Intl., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on November 4, 1997, 112 days after receiving the submission on July 15, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K972655 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1997
Decision Date November 04, 1997
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

Similar Devices — IZI System, X-ray, Angiographic

All 196
IC-Flow? Imaging System 2.0
K243645 · Diagnostic Green GmbH · Sep 2025
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
Modus IR
K231986 · Synaptive Medical, Inc. · Mar 2024
EXPLORER AIR? II (8001, 8002, 8003); EXPLORER AIR? Sterile Drape (8004)
K234090 · Surgvision GmbH · Mar 2024
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · Carl Zeiss Meditec, Inc. · Jun 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · Novadaq Technologies Ulc (A Part of Stryker) · Jun 2023