Itc Bunji Platinum Embolization Coil

FDA 510(k) K925523 · Interventional Therapeutics Corp.

Substantially Equivalent

510(k) numberK925523

Submission

Device name
Itc Bunji Platinum Embolization Coil
Applicant
Interventional Therapeutics Corp.
South San Francisco, CA, US
Received
November 2, 1992
Decision date
March 23, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HCG – Device, Neurovascular Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5950
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code HCG

510(k)DeviceApplicantDecision
K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special Cerenovus, Inc.08/14/2026SE
K261772Target Xtra Detachable CoilHCG · Special Stryker Neurovscular06/24/2026SE
K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.05/20/2026SE
K254221Optima Coil System (OptiOne Coil System)HCG · Special Balt USA, LLC01/27/2026SE
K252694Target Detachable CoilHCG · Traditional Stryker Neurovascular12/11/2025SE
K251832InZone IST Detachment System; IZDS Connecting CableHCG · Special Stryker Neurovascular10/17/2025SE
K252700Optima Coil System (Optima Packing Coil System)HCG · Special Balt USA, LLC09/26/2025SE
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.09/30/2024SE
K242582Optima Coil System (OptiBlock Line Extension)HCG · Special Balt USA, LLC09/27/2024SE
K242243Target Detachable CoilsHCG · Special Stryker Neurovscular08/29/2024SE

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K945588Disposable 1CC Syringe with Luer LockFMF · Traditional 02/10/1995SE
K944354Contour EmboliHCG · Traditional 12/13/1994SE
K930456Intherm Single-Stick Radially Expanding DilatorKNT · Traditional 11/17/1993SE
K914866Itc Contour Emboli, ModificationHCG · Traditional 11/09/1993SE
K931025Intherm Stasis Valve SystemFGE · Traditional 09/28/1993SE
K931278Intherm Single-Stick Radially Expanding DilatorGCJ · Traditional 07/23/1993SE
K922609Itc Catheters W/ HydromerDQY · Traditional 04/30/1993SE
K925876Itc Bunji Platinum Embolization CoilHCG · Traditional 04/15/1993SE

Questions and answers

When was Itc Bunji Platinum Embolization Coil cleared by the FDA?

Itc Bunji Platinum Embolization Coil (K925523) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 141 days after the submission was received.

What is the product code of K925523?

The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.