510(k) · Cleared

Cleared

Usa Series Laparoscopes

K013165510(k) TraditionalCleared Jan 18, 2002119-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

Circon Acmi · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jan 18, 2002 as substantially equivalent to K991718 (Richard Wolf Medical Instruments Corp., 1999) and 4 other predicates after a 119-day review. Its family tree reaches back 1 generation to 1996. 117 later devices descend from it.

Decided: Jan 18, 2002
Review: 119 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K955845 (1996). 5 ancestors in all. 117 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK955845 LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod LensSurgical Image Laboratories, Inc. · 1996
This deviceK013165 Usa Series LaparoscopesCircon Acmi · 2002
Descendant · cites it directly · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
Descendant · 2 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
Descendant · 3 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
Descendant · 3 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
Descendant · 4 generations on · 76 of its ownK142310 Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014

Showing 5 of 117 descendants. See all descendants

Descendants cleared per year

2004high 18 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 117 · See all

K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · cites it directly106descendants
K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 2 generations on104descendants
K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 3 generations on103descendants
K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 3 generations on87descendants
K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014 · 4 generations on76descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955845	LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens	Surgical Image Laboratories, Inc.	1996	—
0 (this device)	K013165	Usa Series Laparoscopes	Circon Acmi	2002	—
+1	K091515	Spy Scope Intra-Operative Operating System	Novadaq Technologies, Inc.	2009	1
+2	K101077	DA Vinci Fluorescence Imaging Vision System, Model FF 100	Intuitive Surgical, Inc.	2011	2
+3	K124031	DA Vinci Fluorescence Imaging Vision System	Intuitive Surgical, Inc.	2013	—
+3	K141077	DA Vinci Firefly Imaging System	Intuitive Surgical, Inc.	2014	2
+4	K142310	Stryker Infrared Fluorescence (IRF) Imaging System	Stryker Endoscopy	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2009	1	0
2011	1	0
2013	1	0
2014	2	0
2015	3	0
2016	4	0
2017	4	0
2018	4	0
2019	4	0
2020	9	0
2021	10	0
2022	11	0
2023	14	0
2024	14	0
2025	16	0
2026	18	0

FIG. 1 — Lineage of K013165, 1996–2026Source: 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? (5)

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
*	K991718	Operating Laparoscope, 10-5 MM, Angeled, Operating Laparoscope 12-7MM, Angled, Operating… Summary page 1 …, CA 93117 Common or Usual Name Laparoscopes Classification Name Laparoscope, General and Plastic Surgery Predicate Devices Richard Wolf"'s Operating Laparoscopes (K991718); Smith and Nephew Dyonics 2.7 mm Microlaparoscope (K982149); Karl Storz's MVM 3.3 mm Microendoscope (K972504); Surgical Image…	Richard Wolf Medical Instruments Corp.	1999	—
*	K982149	Smith & Nephew Dyonics Microlaparoscope Summary page 1 …n Name Laparoscope, General and Plastic Surgery Predicate Devices Richard Wolf"'s Operating Laparoscopes (K991718); Smith and Nephew Dyonics 2.7 mm Microlaparoscope (K982149); Karl Storz's MVM 3.3 mm Microendoscope (K972504); Surgical Image Laboratories, Inc.'s Model L1100, 103, and 104 Laparoscopes…	Smith & Nephew, Inc.	1998	—
*	K972504	MVM 3.3 MM Microendoscope Summary page 1 …redicate Devices Richard Wolf"'s Operating Laparoscopes (K991718); Smith and Nephew Dyonics 2.7 mm Microlaparoscope (K982149); Karl Storz's MVM 3.3 mm Microendoscope (K972504); Surgical Image Laboratories, Inc.'s Model L1100, 103, and 104 Laparoscopes (K955845); and Surgical Image Laboratories, Inc.'s…	KARL STORZ Endoscopy-America, Inc.	1997	—
*	K955845	LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod Lens Summary page 1 …yonics 2.7 mm Microlaparoscope (K982149); Karl Storz's MVM 3.3 mm Microendoscope (K972504); Surgical Image Laboratories, Inc.'s Model L1100, 103, and 104 Laparoscopes (K955845); and Surgical Image Laboratories, Inc.'s 3.5 mm Laparoscope (K001594); N\\DC - 66763/1 - #1380464 v2 A2/5/65 I…	Surgical Image Laboratories, Inc.	1996	—
*	K001594	3.5 MM Laparoscope (LG100, LG103) Summary page 1 …roendoscope (K972504); Surgical Image Laboratories, Inc.'s Model L1100, 103, and 104 Laparoscopes (K955845); and Surgical Image Laboratories, Inc.'s 3.5 mm Laparoscope (K001594); N\\DC - 66763/1 - #1380464 v2 A2/5/65 Intended Use CIRCON's USA Series™ Laparoscopes have the same general i…	Surgical Image Laboratories, Inc.	2000	—

Also cleared against K991718: 1 other device →

What descends from it? (117)

See all 117

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

Number	Device	Applicant	Decided	Descendants
K091515	Spy Scope Intra-Operative Operating System	Novadaq Technologies, Inc.	2009	106
K151593	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	2015	8
K042069	Invisio Irl Digital Rigid Laparoscope System	Acmi Corporation	2004	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?

None of the 5 ancestors has a recall.
Of its descendants, K091515 (Novadaq Technologies, Inc., 2009) has gone furthest, with 106 descendants of its own.
1 other device also cites its predicate K991718.

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?

CIRCON's USA Series™ Laparoscopes are intended for use by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures. These include, but are not limited to, laparoscopic procedures used in general surgical procedures, cholecystectomy, colon resection or therapeutic thoracoscopy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013165: Usa Series Laparoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013165

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026