510(k) · Cleared

Cleared

Laparocision Scope Controller System

K050027510(k) TraditionalCleared Jan 27, 200521-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

Gmp/Companies, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jan 27, 2005 as substantially equivalent to K931783 (Computer Motion, Inc., 1993) after a 21-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided: Jan 27, 2005
Review: 21 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K931783 (1993). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
This deviceK050027 Laparocision Scope Controller SystemGmp/Companies, Inc. · 2005
Descendant · cites it directly · 1 of its ownK082233 VIKYEndocontrol · 2008
Descendant · 2 generations on · 0 of its ownK122820 Viky UPEndocontrol · 2013

Most influential descendants

Showing 2 of 2 · See all

K082233VIKYEndocontrol · 2008 · cites it directly1descendant
K122820Viky UPEndocontrol · 2013 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931783	Aesop (Automated Endoscopic System for Optimal Pos	Computer Motion, Inc.	1993	—
0 (this device)	K050027	Laparocision Scope Controller System	Gmp/Companies, Inc.	2005	—
+1	K082233	VIKY	Endocontrol	2008	—
+2	K122820	Viky UP	Endocontrol	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2013	1	0

FIG. 1 — Lineage of K050027, 1993–2013Source: 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? (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
*	K931783	Aesop (Automated Endoscopic System for Optimal Pos Summary page 1 …Inc. LaparocisionTM Scope Controller System is substantially equivalent to the Computer Motion Inc. AESOP System and Accessories that was cleared by FDA under K93 1783 on November 22, 1993. B. DEVICE DESCRIPTION The GMPISurgical Solutions LaparocisionTM Scope Controller System allows for…	Computer Motion, Inc.	1993	—

Also cleared against K931783: 6 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K082233	VIKY	Endocontrol	2008	1

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?

Its one ancestor has no recall.
Of its descendants, K082233 (Endocontrol, 2008) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K931783.

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 GMPiSurgical Solutions Inc. LaparocisionTM Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050027: Laparocision Scope Controller System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050027

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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