Guglielmi Detachable Coil
FDA 510(k) K962503 · Target Therapeutics
510(k) numberK962503
Submission
- Device name
- Guglielmi Detachable Coil
- Applicant
- Target Therapeutics
Freemont, CA, US - Received
- June 27, 1996
- Decision date
- September 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HCG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | Cerenovus, Inc. | 08/14/2026SE |
| K261772 | Target Xtra Detachable CoilHCG · Special | Stryker Neurovscular | 06/24/2026SE |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | Balt USA, LLC | 01/27/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | Stryker Neurovascular | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | Stryker Neurovascular | 10/17/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | Balt USA, LLC | 09/26/2025SE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
More from Stryker Neurovscular
| 510(k) | Device | Decision |
|---|---|---|
| K965071 | Detachable Slicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964488 | Detachable Silicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964210 | Retriever IIDQO · Traditional | 10/31/1997SE |
| K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…DQX · Traditional | 07/14/1997SE |
| K965189 | SpinnakerKRA · Traditional | 03/24/1997SE |
| K964112 | Berenstein CoilKRD · Traditional | 02/26/1997SE |
| K963307 | GDC Patient Return Electtrode Model 45021HCG · Traditional | 12/17/1996SE |
| K961923 | Berenstein CoilHCG · Traditional | 08/15/1996SE |
| K960705 | Guglielmi Detachable CoilHCG · Traditional | 05/21/1996SE |
| K960806 | Turbo TrackerDQO · Traditional | 05/02/1996SE |
Questions and answers
When was Guglielmi Detachable Coil cleared by the FDA?
Guglielmi Detachable Coil (K962503) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 85 days after the submission was received.
What is the product code of K962503?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.