510(k) Report

FDA applicant

Davol, Inc.

Cranston, RI51 decisions1977–202525 recalls

FDA records 51 decisions for Davol, Inc. (Cranston, RI) from 1977 to 2025: 50 510(k) clearances and 1 original PMA approval. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and CAC (Apparatus, Autotransfusion). Its devices cite 2 predicates, 0 of them its own earlier devices. 25 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.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2007high 2 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

8in 2024

2007: 22008: 12010: 122022: 12024: 8
2007high 12 (2010) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Davol, 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?

  • GCJLaparoscope, General & Plastic Surgery6decisions
  • CACApparatus, Autotransfusion5decisions
  • HRXArthroscope5decisions
  • FTLMesh, Surgical, Polymeric4decisions
  • GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered4decisions
  • HETLaparoscope, Gynecologic (And Accessories)3decisions

Also: GCA (2), HFG (2), GEI (2), LJS (2), KDQ (2), JOL (1).

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 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.

  • K912702Plastic Attachable Dual PortDavol, Inc. · 19913cite it
  • K003323Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 20012cite it
  • K791137Single Use Monopolar Hand Control PencilDavol, Inc. · 19792cite it
  • K902722Bard Laparoscopic Irrigator Pump SystemDavol, Inc. · 19901cites it
  • K792281Usher's Marlex Tubular MeshDavol, Inc. · 19791cites it
  • K930147Surgical Mesh Delivery System, General SurgeryDavol, Inc. · 19931cites it

What has FDA decided for it lately?

  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025
  • K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc. · 2025
  • P050038Arista AH Absorbable HemostatDavol, Inc. · 2006
  • K031213Aquasens Fluid Monitoring SystemDavol, Inc. · 2003
  • K030307Davol Arthrovent Outflow TubingDavol, Inc. · 2003
  • K003323Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 20013 recalls
  • K003790Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004…Davol, Inc. · 20001 recall
  • K931899Davol AtsDavol, Inc. · 1994

All 51 as Davol, Inc. →

What has been recalled?

25 recalls linked to its devices; the latest:

  • K914910Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and…Jan 9, 2024Class II
  • K914910Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and…Jan 9, 2024Class II
  • K914910Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar…Jan 9, 2024Class II
  • K914910Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and…Jan 9, 2024Class II
  • K914910Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and…Jan 9, 2024Class II
  • K914910Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar…Jan 9, 2024Class II

Other applicant names beginning “Davol”

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

Davol Inc., Sub. C. R. Bard, Inc. 25Davol Inc., Subsidiary of C. R. Bard, Inc. 3Davol, Inc., A Subsidiary of C.R. Bard, Inc. 2Davol Inc., Subsidiary of C.R. Bard 1