510(k) Report

FDA applicant

Microsurge, Inc.

Needham, MA15 decisions1991–199612 recalls

FDA records 15 decisions for Microsurge, Inc. (Needham, MA) from 1991 to 1996: 15 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). 12 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Microsurge, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • GCJLaparoscope, General & Plastic Surgery4decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • FZPClip, Implantable1decision
  • OCWEndoscopic Tissue Approximation Device1decision
  • HETLaparoscope, Gynecologic (And Accessories)1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K924283Microsurge Detacha-Tip Surgical InstrumentsMicrosurge, Inc. · 19931cites it
  • K912332Microsurge Laser Fiber HolderMicrosurge, Inc. · 19911cites it
  • K964109Microsurge Laparoscopic Permaclip Cartridge with Implantable ClipMicrosurge, Inc. · 19961cites it
  • K922802Microsurge Front-End Grasping DevicesMicrosurge, Inc. · 19931cites it

What has FDA decided for it lately?

  • K964109Microsurge Laparoscopic Permaclip Cartridge with Implantable ClipMicrosurge, Inc. · 1996
  • K960554Detachatip Thoracoscopic ScissorsMicrosurge, Inc. · 1996
  • K955408Microsurge Thoracoscopic InstrumentsMicrosurge, Inc. · 1996
  • K954641Endo-LeaderMicrosurge, Inc. · 1995
  • K954072Microsurge Puncture Close DeviceMicrosurge, Inc. · 1995
  • K954520Microsurge Veress NeedleMicrosurge, Inc. · 1995
  • K953121Microsurge Thoracoscopic Access SystemMicrosurge, Inc. · 1995
  • K951230Microsurge Bipolar GraspersMicrosurge, Inc. · 1995

All 15 as Microsurge, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K924283ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 33cm…Oct 12, 2006
  • K924283ConMed DetachaTip Laparoscopic Instrument: Endoweave Multiple Use Grasper, 5mm x 43cm…Oct 12, 2006
  • K924283ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm…Oct 12, 2006
  • K924283ConMed DetachaTip Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm…Oct 12, 2006
  • K924283ConMed DetachaTip Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm…Oct 12, 2006
  • K924283ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper…Oct 12, 2006