Sdmo Applicator Code: ASN.8236
FDA 510(k) K921961 · Medi-Physics Inc. Dba Nycomed Amersham Imaging
510(k) numberK921961
Submission
- Device name
- Sdmo Applicator Code: ASN.8236
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
Arlington Heights, IL, US - Received
- April 27, 1992
- Decision date
- July 1, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| 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 |
More from Duke University Medical Center
| 510(k) | Device | Decision |
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| K010821 | ECHOSEED/IODINE-125 Seeds, Model 6733KXK · Special | 04/11/2001SE |
| K940632 | I-125 Rapid StrandIWI · Traditional | 09/02/1994SE |
| K915156 | I-125 Seeds Code: 6702KXK · Traditional | 01/06/1992SE |
| K914281 | I-125 Seeds, Code: 6711KXK · Traditional | 11/22/1991SE |
| K914268 | I-125 Seeds in Carrier, Code: 6720KXK · Traditional | 11/22/1991SE |
| K811688 | Tungsten Syringe ShieldIWR · Traditional | 07/02/1981SE |
| K811677 | Krypton CartKPY · Traditional | 07/02/1981SE |
| K811118 | Krypton Masks & TubingIYT · Traditional | 06/02/1981SE |
Questions and answers
When was Sdmo Applicator Code: ASN.8236 cleared by the FDA?
Sdmo Applicator Code: ASN.8236 (K921961) received a 510(k) decision of Substantially Equivalent on July 1, 1992, 65 days after the submission was received.
What is the product code of K921961?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.