Data / Medical devices / United States / RLS Interventional Inc. DBA Inrad
RLS Interventional Inc. DBA Inrad: FDA-registered device maker in Grand Rapids, MI, United States, 13 510(k) clearances
RLS Interventional Inc. DBA Inrad is registered with the FDA (registration 1835568) in Grand Rapids, MI, United States. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 29, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1835568
- FEI number
- 3001237677
- Address
- 4375 Donkers Ct SE, Grand Rapids, MI, United States, 49512
- Owner or operator
- INRAD (9031756)
- Roles
- Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- 14G x 10cm SelectCore Variable Throw Biopsy Device, 14G x 10cm, 10mm PreciseCore Biopsy Device, 14G x 10cm, 20mm PreciseCore Biopsy Device, 14G x 15cm SelectCore Variable Throw Biopsy Device, 14G x 5cm, 10mm PreciseCore Biopsy Device, 14G x 5cm, 20mm PreciseCore Biopsy Device, 18G x 10cm SelectCore Variable Throw Biopsy Device, 18G x 10cm, 10mm PreciseCore Biopsy Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2025 | K243886 | ExpressCore Biopsy Device | KNW | Substantially Equivalent | Inrad, Inc. | accessdata.fda.gov |
| November 7, 2024 | K240429 | Trilogy Tissue Marker | NEU | Substantially Equivalent | Inrad, Inc. | accessdata.fda.gov |
| October 17, 2019 | K183503 | EasyMark Tissue Marker | NEU | Substantially Equivalent | Inrad, Inc. | accessdata.fda.gov |
| November 19, 2009 | K093399 | PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 | KNW | Substantially Equivalent | Inrad | accessdata.fda.gov |
| November 17, 2009 | K093256 | SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 | KNW | Substantially Equivalent | Inrad | accessdata.fda.gov |
| April 24, 2000 | K000612 | ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE | KNW | Substantially Equivalent | Inrad | accessdata.fda.gov |
| July 28, 1998 | K981721 | C0-AXIAL INTRODUCER NEEDLE | KNW | Substantially Equivalent | Inrad | accessdata.fda.gov |
| April 17, 1998 | K980587 | IV DECANTER-FLEXIBLE | LHI | Substantially Equivalent | Inrad | accessdata.fda.gov |
| November 5, 1991 | K913098 | APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 | KNW | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| January 3, 1990 | K896019 | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. | GAA | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| January 5, 1982 | K813368 | DISPOSABLE CHIBA-TYPE NEEDLE | GAA | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| November 16, 1981 | K813019 | PERCUTANEOUS INTRODUCER: SELDINGER STYLE | DYB | Substantially Equivalent | Dip, Inc. | accessdata.fda.gov |
| November 16, 1981 | K812973 | PERCUTANEOUS INTRODUCER COURNAND STYLE | DYB | Substantially Equivalent | Dip, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 20, 2010 | 57531 | Not yet classified | Terminated | Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is intended for use during percutaneous biopsy and drainage procedur | This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Set, I.V. Fluid Transfer
- All makers of Instrument, Biopsy
- All makers of Marker, Radiographic, Implantable
- All makers of Biopsy Needle
Updated April 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.