510(k) Report

FDA applicant

Davol Inc., Sub. C. R. Bard, Inc.

Canston, RI25 decisions1976–201013 recalls

FDA records 25 decisions for Davol Inc., Sub. C. R. Bard, Inc. (Canston, RI) from 1976 to 2010: 24 510(k) clearances and 1 original PMA approval. Most are in product codes FTL (Mesh, Surgical, Polymeric) and HIG (Insufflator, Hysteroscopic). Its devices cite 17 predicates, 2 of them its own earlier devices. 13 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 Davol Inc., Sub. C. R. Bard, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12009: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2022

2007: 62012: 22014: 12022: 2
2007high 6 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Davol Inc., Sub. C. R. Bard, 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?

  • FTLMesh, Surgical, Polymeric8decisions
  • HIGInsufflator, Hysteroscopic5decisions
  • GCJLaparoscope, General & Plastic Surgery3decisions
  • HRXArthroscope3decisions
  • GDWStaple, Implantable2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Also: FQH (1), GEX (1), LMF (1).

Whose devices does it build on?

Its devices cite 17 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 2 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.

  • K061754Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 20064cite it
  • K961492Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010Davol Inc., Sub. C. R. Bard, Inc. · 19964cite it
  • K971745Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 19973cite it
  • K961224Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 19962cite it
  • K092032Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160Davol Inc., Sub. C. R. Bard, Inc. · 20092cite it
  • K081010Bard 3DMAX MeshDavol Inc., Sub. C. R. Bard, Inc. · 20082cite it

What has FDA decided for it lately?

  • K101851Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 20102 recalls
  • K092032Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160Davol Inc., Sub. C. R. Bard, Inc. · 20091 recall
  • K081010Bard 3DMAX MeshDavol Inc., Sub. C. R. Bard, Inc. · 2008
  • K061754Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 2006
  • K061314Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
  • K051848Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079Davol Inc., Sub. C. R. Bard, Inc. · 2005
  • K050610Salute Fixation SystemDavol Inc., Sub. C. R. Bard, Inc. · 20058 recalls
  • K011069Aquasens Fluid Monitoring SystemDavol Inc., Sub. C. R. Bard, Inc. · 2001

All 25 as Davol Inc., Sub. C. R. Bard, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K961492HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle…Jun 7, 2022Class II
  • K961492HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm…Jun 7, 2022Class II
  • K092032Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft…Oct 8, 2014Class II
  • K101851Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790.…Sep 4, 2012Class II
  • K101851Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810.…Sep 4, 2012Class II
  • K050610Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product…Jul 16, 2007

Other applicant names beginning “Davol”

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

Davol, Inc. 51Davol Inc., Subsidiary of C. R. Bard, Inc. 3Davol, Inc., A Subsidiary of C.R. Bard, Inc. 2Davol Inc., Subsidiary of C.R. Bard 1