510(k) Report

FDA applicant

Coalescent Surgical

Sunnyvale, CA9 decisions2000–20044 recalls

FDA records 9 decisions for Coalescent Surgical (Sunnyvale, CA) from 2000 to 2004: 9 510(k) clearances. Most are in product codes FZP (Clip, Implantable) and NJU (Suture, Nonabsorbable, Nitinol). Its devices cite 35 predicates, 25 of them its own earlier devices. 4 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 Coalescent Surgical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coalescent Surgical since 2007.

Recalls per year

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • FZPClip, Implantable7decisions
  • NJUSuture, Nonabsorbable, Nitinol1decision
  • NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)1decision

Whose devices does it build on?

Its devices cite 35 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 54 times; 25 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.

  • K994160Coalescent Surgical Sutured-ClipCoalescent Surgical · 200011cite it
  • K012317Coalescent Surgical U-ClipCoalescent Surgical · 200110cite it
  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 20029cite it
  • K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 20027cite it
  • K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20036cite it
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 20026cite it

What has FDA decided for it lately?

  • K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2004
  • K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20034 recalls
  • K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 20031 recall
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  • K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002
  • K012317Coalescent Surgical U-ClipCoalescent Surgical · 2001
  • K003958Coalescent U-Clip Delivery and Disposal DeviceCoalescent Surgical · 2001

All 9 as Coalescent Surgical →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K031623Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number…Apr 2, 2010
  • K031623VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip…Feb 25, 2008
  • K031623Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip…Feb 8, 2007
  • K024366Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse.…Sep 1, 2005