510(k) · Cleared

Cleared

Pariefix

K032093510(k) TraditionalCleared Oct 22, 2003107-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

Sofradim Production · GCJ Laparoscope, General & Plastic Surgery

Cleared on Oct 22, 2003 as substantially equivalent to K913469 (ETHICON, Inc., 1991) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1991. 15 later devices descend from it.

Decided: Oct 22, 2003
Review: 107 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K913469 (1991). 2 ancestors in all. 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
This deviceK032093 PariefixSofradim Production · 2003
Descendant · cites it directly · 14 of its ownK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
Descendant · 2 generations on · 13 of its ownK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
Descendant · 3 generations on · 6 of its ownK092483 Bard Permafix Fixation System, Model 0113012, 0113014, 0113016…C.R. Bard, Inc. · 2009
Descendant · 3 generations on · 4 of its ownK132134 Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013
Descendant · 4 generations on · 3 of its ownK142873 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable…C.R. Bard, Inc. · 2015

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006high 2 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all

K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006 · cites it directly14descendants
K082396Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…C.R. Bard, Inc. · 2009 · 2 generations on13descendants
K092483Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018C.R. Bard, Inc. · 2009 · 3 generations on6descendants
K132134Optifix Absorbable Fixation SystemC.R. Bard, Inc. · 2013 · 3 generations on4descendants
K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…C.R. Bard, Inc. · 2015 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913469	Endopath Disposable Endoscopic Multifeed Stapler	ETHICON, Inc.	1991	—
0 (this device)	K032093	Pariefix	Sofradim Production	2003	—
+1	K060494	Easytac Anchor. Easytac Delivery System	Medchannel, LLC	2006	—
+2	K082396	Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084…	C.R. Bard, Inc.	2009	—
+3	K092483	Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018	C.R. Bard, Inc.	2009	—
+3	K132134	Optifix Absorbable Fixation System	C.R. Bard, Inc.	2013	—
+4	K142873	OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners…	C.R. Bard, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	2	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 K032093, 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 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
*	K913469	Endopath Disposable Endoscopic Multifeed Stapler Summary page 1 …paroscopic accessory Classification Name: Endoscope and/or accessories 3. PREDICATE DEVICES Ethicon Endopath' EMS K9 13469 Origin Tacker' System K9444 15 Phusis' Absorbable Interference Screw K970879 [same PLA material] 4.…	ETHICON, Inc.	1991	—
*	K944415	Origin Tacker System Summary page 1 …Endoscope and/or accessories 3. PREDICATE DEVICES Ethicon Endopath' EMS K9 13469 Origin Tacker' System K9444 15 Phusis' Absorbable Interference Screw K970879 [same PLA material] 4. DEVICEDESCRIPTION The PAEUEFIX device is an…	Origin Medsystems, Inc.	1994	—
†	K970879	Cardiovit CS-200	Schiller America, Inc.	1997	—

Also cleared against K913469: 2 other devices →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060494	Easytac Anchor. Easytac Delivery System	Medchannel, LLC	2006	14

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?

None of the 2 ancestors has a recall.
Of its descendants, K060494 (Medchannel, LLC, 2006) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K913469.

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 PARIEFIX Endoscopic Stapler is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032093 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032093: Pariefix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032093

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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