FDA product code IWJ: System, Applicator, Radionuclide, Manual
IWJ is the FDA product code for system, applicator, radionuclide, manual. It is a Class I device, regulated under 21 CFR 892.5650 and reviewed by the Radiology panel. FDA has cleared 36 510(k) submissions under IWJ, from 21 different applicants. The average 510(k) review took 147 days (median 88). FDA has posted 11 recalls for IWJ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Applicator, Radionuclide, Manual |
| Device class | Class I |
| Regulation | 21 CFR 892.5650 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWJ clearance
Top IWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mick Radio-Nuclear Instruments, Inc. | 9 | 1992-10-13 |
| Best Industries | 4 | 1994-12-30 |
| Avid N.I.T., Inc. | 3 | 1998-02-17 |
| Manan Medical Products, Inc. | 2 | 1996-12-06 |
| Amersham Corp. | 2 | 1989-02-06 |
16 more applicants have IWJ clearances. See the full list in Caduvo.
Most recent IWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010166 | Imagyn Medical Technologies, Inc. | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | 2001-12-03 | 319 |
| K980997 | Pgk, Inc. | PGK DEVICE (MODIFIED) | 1998-09-28 | 195 |
| K972554 | Avid N.I.T., Inc. | REGANES RADIONUCLIDE SEED MAGAZINE | 1998-02-17 | 224 |
| K973037 | Avid N.I.T., Inc. | N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 | 1998-01-27 | 166 |
| K974118 | Worldwide Medical Technologies, LLC | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET | 1998-01-23 | 84 |
Recalls for IWJ devices
11 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-22.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code IWJ?
IWJ is the FDA product code for system, applicator, radionuclide, manual. It is a Class I device, regulated under 21 CFR 892.5650 and reviewed by the Radiology panel.
What device class is IWJ?
Class I, regulation 21 CFR 892.5650. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWJ?
Across 36 cleared submissions the average was 147 days from receipt to decision (median 88).
Which companies have the most IWJ clearances?
Mick Radio-Nuclear Instruments, Inc. (9); Best Industries (4); Avid N.I.T., Inc. (3); Manan Medical Products, Inc. (2); Amersham Corp. (2).
Have IWJ devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2021-02-22.
Next steps
- Run an FDA pathway report with predicate devices for product code IWJ
- Run a recall and safety report across every IWJ manufacturer
- Watch product code IWJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times