510(k) · Cleared

Cleared

Davol Delivery System

K041641510(k) TraditionalCleared Jul 1, 200414-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jul 1, 2004 after a 14-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.

Decided: Jul 1, 2004
Review: 14 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

15 later devices descend from it, 2 citing it directly.

This deviceK041641 Davol Delivery SystemC.R. Bard, Inc. · 2004
Descendant · cites it directly · 14 of its ownK061754 Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 2006
Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
Descendant · 3 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006high 3 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all

K061754Bard Composite L/P MeshDavol Inc., Sub. C. R. Bard, Inc. · 2006 · cites it directly14descendants
K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 3 generations on5descendants
K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K041641	Davol Delivery System	C.R. Bard, Inc.	2004	—
+1	K061754	Bard Composite L/P Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2006	—
+1	K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	—
+2	K102766	Composix L/P Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2010	2
+3	K110820	Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System	C.R. Bard, Inc.	2011	—
+3	K122436	Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…	C.R. Bard, Inc.	2012	15

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	1	0
2010	3	0
2011	3	0
2012	2	0
2013	1	0
2015	1	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K041641, 2004–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Davol Surgical Mesh Delivery System Named without a submission number			—
*	—	MedChem Surgical Delivery System Named without a submission number			—

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061754	Bard Composite L/P Mesh	Davol Inc., Sub. C. R. Bard, Inc.	2006	14
K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	7

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K061754 (Davol Inc., Sub. C. R. Bard, Inc., 2006) has gone furthest, with 14 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The Davol Delivery System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041641: Davol Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041641

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026