510(k) Report

FDA applicant

Entrigue Surgical, Inc.

San Antonio, TX4 decisions2007–20130 recalls

FDA records 4 decisions for Entrigue Surgical, Inc. (San Antonio, TX) from 2007 to 2013: 4 510(k) clearances. Most are in product codes LYA (Splint, Intranasal Septal) and NWJ (Suture, Recombinant Technology). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2013

2007: 12009: 12012: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Entrigue Surgical, Inc.’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?

  • LYASplint, Intranasal Septal1decision
  • NWJSuture, Recombinant Technology1decision
  • LRCInstrument, Ent Manual Surgical1decision
  • OLLSeptal Stapler/Absorbable Staples1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K121351Sinus Dilation SystemEntrigue Surgical, Inc. · 20123cite it
  • K130354Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)Entrigue Surgical, Inc. · 20131cites it

What has FDA decided for it lately?

  • K130354Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)Entrigue Surgical, Inc. · 2013
  • K121351Sinus Dilation SystemEntrigue Surgical, Inc. · 2012
  • K082750Entact Septal Stapler, Model 610-00100Entrigue Surgical, Inc. · 2009
  • K072470Bioelast 5-0 Suture, Model 500100Entrigue Surgical, Inc. · 2007

All 4 as Entrigue Surgical, Inc. →