510(k) Report

FDA applicant

Micromedics, Inc.

St. Paul, MN29 decisions1983–20245 recalls

FDA records 29 decisions for Micromedics, Inc. (St. Paul, MN) from 1983 to 2024: 29 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and KYZ (Syringe, Irrigating (Non Dental)). Its devices cite 9 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Micromedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 12010: 12011: 12012: 22013: 12024: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2009: 12010: 32014: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Micromedics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Micromedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery5decisions
  • KYZSyringe, Irrigating (Non Dental)4decisions
  • FMFSyringe, Piston4decisions
  • ETDTube, Tympanostomy2decisions
  • KAMCannula, Sinus2decisions
  • CAFNebulizer (Direct Patient Interface)1decision

Also: ETA (1), HBB (1), LFB (1), ESX (1), KDC (1), ETB (1).

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K830228Otological Ventilation Tubes-VariousMicromedics, Inc. · 19835cite it
  • K012868Micromedics Fibrijet Aerosol ApplicatorMicromedics, Inc. · 20014cite it
  • K881020Surgical Sealant Dispenser (SSD)Micromedics, Inc. · 19883cite it
  • K042834Micromedics Fibrijet Air Assisted Endoscopic ApplicatorMicromedics, Inc. · 20053cite it
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 20103cite it
  • K122526360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 20122cite it

What has FDA decided for it lately?

  • K241739Endoscopic Applicator, 41 cmMicromedics, Inc. · 2024
  • K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
  • K122526360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K120608Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K102563Single Cannula Extended ApplicatorMicromedics, Inc. · 2011
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  • K073401Earpopper, Model EP-2000, EP-2100, EP-3000Micromedics, Inc. · 2008
  • K061092Baxter Duplospray Mis ApplicatorMicromedics, Inc. · 2006

All 29 as Micromedics, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K830228Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01…May 12, 2014Class II
  • K883338AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan…Mar 15, 2010
  • K881020ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending…Mar 15, 2010
  • K982667SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard…Mar 15, 2010
  • K883338HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in…Nov 16, 2009

Other applicant names beginning “Micromedics”

FDA records each applicant name separately; these may or may not be the same firm.

Micromedics, Inc. (D/B/A Nordson Medical) 4