510(k) · Cleared

Cleared

Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087

K082396510(k) TraditionalCleared Jan 2, 2009136-day reviewClass II21 CFR 878.4750

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. · GDW Staple, Implantable

Cleared on Jan 2, 2009 as substantially equivalent to K060494 (Medchannel, LLC, 2006) after a 136-day review. Its family tree reaches back 3 generations to 1991. 13 later devices descend from it.

Decided: Jan 2, 2009
Review: 136 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K913469 (1991). 5 ancestors in all. 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
2 generations backK032093 PariefixSofradim Production · 2003
1 generation backK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
This deviceK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
Descendant · cites it directly · 6 of its ownK092483 Bard Permafix Fixation System, Model 0113012, 0113014, 0113016…C.R. Bard, Inc. · 2009
Descendant · cites it directly · 4 of its ownK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
Descendant · 2 generations on · 3 of its ownK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015
Descendant · 2 generations on · 3 of its ownK132698 Fastouch Fixation SystemVia Surgical, Ltd. · 2014
Descendant · 3 generations on · 2 of its ownK162252 FasTouch Fixation SystemVia Surgical, Ltd. · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009high 2 (2013) · low 0 (2010)2026

Most influential descendants

Showing 5 of 13 · See all

K092483Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018C.R. Bard, Inc. · 2009 · cites it directly6descendants
K132134Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013 · cites it directly4descendants
K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…C.R. Bard, Inc. · 2015 · 2 generations on3descendants
K132698Fastouch Fixation SystemVia Surgical, Ltd. · 2014 · 2 generations on3descendants
K162252FasTouch Fixation SystemVia Surgical, Ltd. · 2016 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K913469	Endopath Disposable Endoscopic Multifeed Stapler	ETHICON, Inc.	1991	—
−2	K032093	Pariefix	Sofradim Production	2003	—
−1	K060494	Easytac Anchor. Easytac Delivery System	Medchannel, LLC	2006	—
0 (this device)	K082396	Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084…	C.R. Bard, Inc.	2009	—
+1	K092483	Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018	C.R. Bard, Inc.	2009	—
+1	K132134	Optifix Absorbable Fixation System	C.R. Bard, Inc.	2013	—
+2	K142873	OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners…	C.R. Bard, Inc.	2015	—
+2	K132698	Fastouch Fixation System	Via Surgical, Ltd.	2014	—
+3	K162252	FasTouch Fixation System	Via Surgical, Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2013	2	0
2014	1	0
2015	1	0
2016	1	0
2017	2	0
2019	2	0
2021	2	0

FIG. 1 — Lineage of K082396, 1991–2021Source: 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 GDW? 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 GDW device

#1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.1 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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
*	K060494	Easytac Anchor. Easytac Delivery System Summary page 1 …lantable C. Predicate Device Name Trade name: Permasorb Disposable Fixation Device (K060494) D. Device. Des~cription The Davol Absorbable Fastener System is designed to deliver an absorbable fastener into tissue or.…	Medchannel, LLC	2006	—

Also cleared against K060494: 1 other device →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K092483	Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018	C.R. Bard, Inc.	2009	6
K132134	Optifix Absorbable Fixation System	C.R. Bard, Inc.	2013	4
K111153	Sorbafix (TM) Absorbable Fixation System, Permafix (TM) Fixation System	C.R. Bard, Inc.	2011	1
K201934	Surgimatix Absorbable Fixation System	Surgimatix, Inc.	2021	0

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?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K092483 (C.R. Bard, Inc., 2009) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K060494.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, 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	8	56	9	2,401
2008	7	57	0	2,380
2009	13	27	22	4,014
2010	10	39	2	3,768
2011	11	49	9	3,826
2012	9	45	11 (1)	3,717
2013	13	49	1	3,777
2014	15	63	0	4,784
2015	8	111	6	4,899
2016	11	96	2	5,106
2017	13	103	3	11,643
2018	7	90	3	14,914
2019	12	205	4 (4)	16,600
2020	10	88	11	12,332
2021	9	233	0	13,015
2022	7	89	0	13,605
2023	4	267	1	14,623
2024	2	—	0	13,280
2025	3	111	3	11,905
2026	3	141	0	—

What is it indicated for?

The Davol Absorbable Fastener System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082396 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082396: Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082396

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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