Cook Brach Needle/Radio Deliv Cath/Flexi Flexicath
FDA 510(k) K940550 · Cook, Inc.
510(k) numberK940550
Submission
- Device name
- Cook Brach Needle/Radio Deliv Cath/Flexi Flexicath
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- February 7, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K973638 | N.I.T., Inc. Needle Guiding TemplateIWJ · Traditional | Avid N.I.T., Inc. | 12/23/1997SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | Promex, Inc. | 11/21/1997SE |
| K963743 | Manan Prostate Uni-LockIWJ · Traditional | Manan Medical Products, Inc. | 12/06/1996SE |
| K951052 | Weeks ApplicatorIWJ · Traditional | Duke University Medical Center | 08/22/1996SE |
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Questions and answers
When was Cook Brach Needle/Radio Deliv Cath/Flexi Flexicath cleared by the FDA?
Cook Brach Needle/Radio Deliv Cath/Flexi Flexicath (K940550) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 191 days after the submission was received.
What is the product code of K940550?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.