510(k) · Cleared

Cleared

Birtcher Laparoscope and Accessories

K932987510(k) TraditionalCleared Apr 25, 1994311-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

Birtcher Medical Systems, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 25, 1994 after a 311-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 41 later devices descend from it.

Decided: Apr 25, 1994
Review: 311 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

41 later devices descend from it, 2 citing it directly.

This deviceK932987 Birtcher Laparoscope and AccessoriesBirtcher Medical Systems, Inc. · 1994
Descendant · cites it directly · 37 of its ownK020310 Davlite Microendoscope & AccessoriesDavlite Technologies · 2002
Descendant · 2 generations on · 31 of its ownK040604 Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004
Descendant · 3 generations on · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
Descendant · 2 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
Descendant · 3 generations on · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

1998high 4 (2015) · low 0 (2000)2026

Most influential descendants

Showing 5 of 41 · See all

K020310Davlite Microendoscope & AccessoriesDavlite Technologies · 2002 · cites it directly37descendants
K040604Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004 · 2 generations on31descendants
K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 3 generations on30descendants
K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · 2 generations on21descendants
K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K932987	Birtcher Laparoscope and Accessories	Birtcher Medical Systems, Inc.	1994	—
+1	K020310	Davlite Microendoscope & Accessories	Davlite Technologies	2002	—
+2	K040604	Innervue Diagnostic Scope System	Arthrotek, Inc.	2004	—
+3	K072879	Innervue Diagnostic Scope System	Biomet Orthopedics, Inc.	2008	2
+2	K082293	Surgview Integrated Visualization System	Biovision Technologies, LLC	2008	—
+3	K093717	C-Mor Visualization Device	Axis Surgical Technologies, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2002	1	0
2004	2	0
2005	1	0
2006	1	0
2008	2	0
2009	2	0
2010	3	0
2011	1	0
2012	2	0
2014	2	0
2015	4	0
2016	2	0
2017	1	0
2018	2	0
2019	3	0
2020	1	0
2021	3	0
2022	2	0
2024	2	0
2026	2	0

FIG. 1 — Lineage of K932987, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K020310	Davlite Microendoscope & Accessories	Davlite Technologies	2002	37
K983538	Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability	Solos Endoscopy, Inc.	1998	5

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?

Of its descendants, K020310 (Davlite Technologies, 2002) has gone furthest, with 37 descendants of its own.

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	—

https://510kreport.com/device/K932987 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932987: Birtcher Laparoscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932987

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026