Data / Medical devices / United States / Micromedics, Inc.
Micromedics, Inc.: FDA-registered device maker in Saint Paul, MN, United States, 15 510(k) clearances
Micromedics, Inc. is registered with the FDA (registration 2183425) in Saint Paul, MN, United States. It lists 6 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 15, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183425
- Address
- 1270 Eagan Industrial Road Suite 120, Saint Paul, MN, United States, 55121
- Owner or operator
- Micromedics, Inc. (2183425)
- Roles
- Manufacturer
- First device listed
- November 18, 1997
- Registered through
- 2026
- Brand names listed
- 360° Gas Assisted Endoscopic Applicator, Arthrex BioXPress, BAXTER DUPLOSPRAY MIS APPLICATOR, Baxter Duplotip Surgical Sealant Ap, DuploSpray MIS Regulator, Duplospray MIS Applicator with Snap Lock, Duplotip with Snap Lock, ENDOSCOPIC CATHETER INTRODUCER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| July 15, 2024 | K241739 | Endoscopic Applicator, 41 cm | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| November 30, 2017 | K173385 | Graft Delivery, DePuy Synthes | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| October 6, 2017 | K172672 | Endoscopic Applicator, 41 cm | GCJ | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| July 7, 2015 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| January 8, 2013 | K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| November 16, 2012 | K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| March 15, 2012 | K120608 | ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| March 15, 2011 | K102563 | SINGLE CANNULA EXTENDED APPLICATOR | KYZ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| June 9, 2010 | K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| September 13, 2006 | K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| February 11, 2005 | K042834 | MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| October 4, 2004 | K033589 | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| October 29, 2001 | K012868 | MICROMEDICS FIBRIJET AEROSOL APPLICATOR | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| August 23, 1988 | K883338 | SURGICAL SEALANT APPLICATOR | KYZ | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| March 25, 1988 | K881020 | SURGICAL SEALANT DISPENSER (SSD) | KYZ | Substantially Equivalent | Micromedics, 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 |
|---|---|---|---|---|---|---|
| October 20, 2016 | 75890 | Class II | Terminated | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide | The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance. | accessdata.fda.gov |
| March 15, 2010 | 56874 | Not yet classified | Terminated | AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Syringe, Piston
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Accessories, Catheter
Updated July 15, 2024. 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.