510(k) · Cleared

Cleared

Surgical Retractors

K112659510(k) TraditionalCleared Mar 9, 2012178-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

Surgical Innovations Plc · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 9, 2012 as substantially equivalent to K092684 (Cardinal Health, Inc., 2010) and 2 other predicates after a 178-day review. Its family tree reaches back 2 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall.

Decided: Mar 9, 2012
Review: 178 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K933008 (1994). 5 ancestors in all, the oldest K914190 (1992). No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK933008 Retractors and ScraperBaxter Healthcare Corp · 1994
1 generation backK092684 Laparoscopic RetractorsCardinal Health, Inc. · 2010 · Recalled (Class I)
This deviceK112659 Surgical RetractorsSurgical Innovations Plc · 2012

Class I recalls in this family

K092684 Laparoscopic Retractorsdirect predicate · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K933008	Retractors and Scraper	Baxter Healthcare Corp	1994	—
−1	K092684	Laparoscopic Retractors	Cardinal Health, Inc.	2010	Class I
0 (this device)	K112659	Surgical Retractors	Surgical Innovations Plc	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	2	0

FIG. 1 — Lineage of K112659, 1994–2012Source: 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.

1 device in this family has a Class I recall. 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? (3)

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
*	K092684	Laparoscopic Retractors Summary page 1 …cope, General and Plastic Surgery (21 CFR 876.1500, Product Code GOJ) Equivalent to: Laparoscopic Retractors (Diamond-Flex) (K092684) Cardinal Health Nathanson Liver Retractor (K(942002) Automated Medical Products…	Cardinal Health, Inc.	2010	Class I
*	K942002	Retractor Summary page 2 …bstantial Laparoscopic Retractors- Cardinal Health, Inc. (K092684) Equivalence: Nathanson Liver Retractor-Automated Medical Products (K942002) Endlo-Retract- Covidien (K914190) {…	Automated Medical Products Corp.	1994	—
*	K914190	Auto Suture (R) Endoscopic Fan Retractor Summary page 2 …th, Inc. (K092684) Equivalence: Nathanson Liver Retractor-Automated Medical Products (K942002) Endlo-Retract- Covidien (K914190) { 5-2…	United States Surgical, A Division of Tyco Healthc	1992	—

Also cleared against K092684: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K092684Laparoscopic RetractorsCardinal Health, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
1 other device also cites its predicate K092684.

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. 2012, this device’s year, is highlighted.

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?

This device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate or retract organs and tissues to provide better access as well as visualization and stabilization of surgical sites.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112659: Surgical Retractors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112659

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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