510(k) · Cleared

Cleared

Ceruleau Electrosurgical Probe

K101711510(k) TraditionalCleared Jul 1, 201013-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

Nuortho Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 1, 2010 as substantially equivalent to K011083 (Arthrocare Corp., 2001) and 4 other predicates after a 13-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jul 1, 2010
Review: 13 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K944992 (1995). 9 ancestors in all, the oldest K803214 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944992 ElectrodesLinvatec Corp. · 1995
1 generation backK993885 Ultrablator ElectrodeLinvatec Corp. · 2000
This deviceK101711 Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944992	Electrodes	Linvatec Corp.	1995	—
−1	K993885	Ultrablator Electrode	Linvatec Corp.	2000	—
0 (this device)	K101711	Ceruleau Electrosurgical Probe	Nuortho Surgical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1994	1	0
1999	2	0
2000	1	0
2001	1	0
2002	1	0

FIG. 1 — Lineage of K101711, 1995–2010Source: 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? (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
*	K011083	Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand Summary page 1 …device and accessories Classification Code: 21 CFR §878.4400 Product Code: GEl Equivalent Device(s): * ArthroCare Arthrowands (K01 1083) Stryker SERFAS (K991960) Mitek VAPR S90 (K(002422)…	Arthrocare Corp.	2001	—
*	K991960	Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas… Summary page 1 …ication Code: 21 CFR §878.4400 Product Code: GEl Equivalent Device(s): * ArthroCare Arthrowands (K01 1083) Stryker SERFAS (K991960) Mitek VAPR S90 (K(002422) *ConMed UltrAblator (K(993685)…	Stryker Endoscopy	1999	—
*	K002422	Varpr 3.5MM 90 Suction Electrode for Use with Vapr System Summary page 1 …valent Device(s): * ArthroCare Arthrowands (K01 1083) Stryker SERFAS (K991960) Mitek VAPR S90 (K(002422) ConMed UltrAblator (K(993685) ConMed Bicap Superconductor TM (K0…	Mitek Products	2000	—
*	K993885	Ultrablator Electrode Our reading of the summary gave K993685, FDA’s number for Biopack (Bioscan, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ConMed UltrAblator”.	Linvatec Corp.	2000	—
*	K012018	Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910 Summary page 1 …Mitek VAPR S90 (K(002422) ConMed UltrAblator (K(993685) *ConMed Bicap Superconductor TM (K012018) Device Description: The GERULEAU TM Electrosurgical Probe is a bipolar device designed to dire…	Acmi Corporation	2002	—

Also cleared against K011083: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
None of the 9 ancestors has a recall.
5 other devices also cite its predicate K011083.

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. 2010, this device’s year, is highlighted.

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 NuOrtho CERULEAU Probes are indicated for resection, coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. These procedures include the following indications: Resection and Excision: Acetabular Labrum (Hip); Articular Labrum (All Joints); Capsule (All Joints); Capsular Release (Knee); Cartilage Flaps (Knee); Cysts (All Joints); Discoid Meniscus (Knee); Frozen Shoulder Release (Shoulder); Glenoid Labrum…

Read the full statement (171 words)

Resection and Excision: Acetabular Labrum (Hip); Articular Labrum (All Joints); Capsule (All Joints); Capsular Release (Knee); Cartilage Flaps (Knee); Cysts (All Joints); Discoid Meniscus (Knee); Frozen Shoulder Release (Shoulder); Glenoid Labrum (Shoulder); Labral Tear (Shoulder); Lateral Release (Knee); Ligament (All Joints); Loose Bodies (All Joints); Meniscal Cystectomy (Knee); Meniscectomy (Knee); Plica Removal (All Joints); Scar Tissue (All Joints); Soft Tissue (All Joints); Synovial Membrane (All Joints); Tendon (All Joints); Triangular Fibrocartilage (TFCC) (Wrist); Villusectomy (Knee).

Debridement: ACL/PCL (Knee); Acromioplasty (Shoulder); Articular Cartilage (All Joints); Bursectomy (All Joints); Chondroplasty (All Joints); Facia (All Joints); Ligament (All Joints); Notchplasty (Knee); Scar Tissue (All Joints); Soft Tissue (All Joints); Subacromial Decompression (Shoulder); Synovectomy (All Joints); Tendon (All Joints).

Coagulation: ACL/PCL (Knee); Articular Cartilage (All Joints); Carpal Ligaments (Wrist); Glenohumeral Capsule (Shoulder); Ligament (All Joints); Medial Retinaculum (Knee); Rotator Cuff (Shoulder); Tendon (All Joints); Wrist Tendons (Wrist).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101711: Ceruleau Electrosurgical Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101711

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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