Afterloading Gynecological Applicator
FDA 510(k) K813230 · Esi
510(k) numberK813230
Submission
- Device name
- Afterloading Gynecological Applicator
- Applicant
- Esi
Mchenry, IL, US - Received
- November 10, 1981
- Decision date
- December 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010166 | Imagyn Isosleeve / Isostar Needle SystemIWJ · Traditional | Imagyn Medical Technologies, Inc. | 12/03/2001SE |
| K980997 | PGK Device (Modified)IWJ · Traditional | Pgk, Inc. | 09/28/1998SE |
| K972554 | Reganes Radionuclide Seed MagazineIWJ · Traditional | Avid N.I.T., Inc. | 02/17/1998SE |
| K973037 | N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000IWJ · Traditional | Avid N.I.T., Inc. | 01/27/1998SE |
| K974118 | Worldwide Medical Technologies Seed Implant Needle SetIWJ · Traditional | Worldwide Medical Technologies, LLC | 01/23/1998SE |
| K973786 | Northwest Radiation Therapy Products, Precision Stepper and GuideIWJ · Traditional | Nw Radiation Therapy Products | 01/02/1998SE |
| 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 Afterloading Gynecological Applicator cleared by the FDA?
Afterloading Gynecological Applicator (K813230) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 49 days after the submission was received.
What is the product code of K813230?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.