510(k) · Cleared

Cleared

Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910

K012018510(k) TraditionalCleared Jul 16, 2002383-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acmi Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 16, 2002 as substantially equivalent to K803214 (American Cystocope Makers, Inc., 1981) and 1 other predicate after a 383-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.

Decided: Jul 16, 2002
Review: 383 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K803214 (1981). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK803214 Acmi Bipolar Hemostatic ElectrodeAmerican Cystocope Makers, Inc. · 1981
This deviceK012018 Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910Acmi Corporation · 2002
Descendant · cites it directly · 0 of its ownK102275 Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220…Thermedx, LLC · 2011
Descendant · cites it directly · 0 of its ownK101711 Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010

Most influential descendants

Showing 2 of 2 · See all

K102275Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240Thermedx, LLC · 2011 · cites it directly0descendants
K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K803214	Acmi Bipolar Hemostatic Electrode	American Cystocope Makers, Inc.	1981	—
0 (this device)	K012018	Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910	Acmi Corporation	2002	—
+1	K102275	Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230…	Thermedx, LLC	2011	—
+1	K101711	Ceruleau Electrosurgical Probe	Nuortho Surgical, Inc.	2010	—

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
2010	1	0
2011	1	0

FIG. 1 — Lineage of K012018, 1981–2011Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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
*	K803214	Acmi Bipolar Hemostatic Electrode Summary page 1 …21 CFR 876.4300 Substantially Equivalent Devices: The BICAP COAG Bipolar Laparoscopy Probe to the ACMI Bipolar Hemostatic Electrode (K8032 14) and the Cabot Medical Surgiflex Suction-Irrigation Probe (K932626). Description of Device: The 5 mm ACMI BICAP…	American Cystocope Makers, Inc.	1981	—
*	K932626	Cabot Medical Surgiflex (R) Suction-Irrigation Prob Summary page 1 …s: The BICAP COAG Bipolar Laparoscopy Probe to the ACMI Bipolar Hemostatic Electrode (K8032 14) and the Cabot Medical Surgiflex Suction-Irrigation Probe (K932626). Description of Device: The 5 mm ACMI BICAP COAG Bipolar Laparoscopy Probe (32 cm working length) is designed f…	Cabot Medical Corp.	1994	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K102275	Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240	Thermedx, LLC	2011	0
K101711	Ceruleau Electrosurgical Probe	Nuortho Surgical, Inc.	2010	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 2 ancestors has a recall.
Of its descendants, K102275 (Thermedx, LLC, 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The BICAP COAG Bipolar Laparoscopy Probe is indicated for use in laparoscopic procedures to provide bipolar coagulation, blunt dissection, irrigation, and aspiration.

The BICAP COAG Probe may be used in a variety of gastrointestinal, urological and gynecological procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K012018 · printed Nov 3, 2026

Cite this page

510(k) Report. “K012018: Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012018

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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