510(k) · Cleared

Cleared

CURIS II RF Generator (REF 360100-05)

K251813510(k) TraditionalCleared Feb 11, 2026243-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

Sutter Medizintechnik GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 11, 2026 as substantially equivalent to K171869 (Sutter Medizintechnik GmbH, 2018) after a 243-day review. Its family tree reaches back 5 generations to 1994.

Decided: Feb 11, 2026
Review: 243 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K933157 (1994). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
4 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
3 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
2 generations backK100390 Surgimax/ Surgimax PlusElliquence, LLC · 2010
1 generation backK171869 Sutter CURIS RF GeneratorSutter Medizintechnik GmbH · 2018
This deviceK251813 CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K933157	Erbotom Icc 200	Erbe USA, Inc.	1994	—
−4	K013255	Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF	Ellman Intl., Inc.	2001	—
−3	K061174	Surgi-Max	Ellman Int'L, Inc.	2006	—
−2	K100390	Surgimax/ Surgimax Plus	Elliquence, LLC	2010	—
−1	K171869	Sutter CURIS RF Generator	Sutter Medizintechnik GmbH	2018	—
0 (this device)	K251813	CURIS II RF Generator (REF 360100-05)	Sutter Medizintechnik GmbH	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K251813, 1994–2026Source: 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 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? (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
*	K171869	Sutter CURIS RF Generator Summary page 6 …el: General & Plastic Surgery Regulatory Class: II Product Code: GEI 510k #: K2518113 IV PREDICATE DEVICE K171869 – Sutter CURIS® RF Generator V. DEVICE DESCRIPTION The Sutter CURIS® II RF Generator is a compact source of high radiofrequen…	Sutter Medizintechnik GmbH	2018	—

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 32 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
None of the 6 ancestors has a recall.

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. 2026, 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 Sutter Sutter CURIS® II RF Generator is intended for: Orthopedic, arthroscopic, spinal and neurosurgical: For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures. For soft tissue resection and coagulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist. Cutting: Snoring, submucosal palatal shrinkage, traditional…

Read the full statement (164 words)

The Sutter Sutter CURIS® II RF Generator is intended for:

Orthopedic, arthroscopic, spinal and neurosurgical:

For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures.

For soft tissue resection and coagulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting:

Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, blepharoplasty.

Blended Cutting and Coagulation:

Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps.

Hemostasis and nonablative Coagulation:

Control of bleeding, epilation, teleangiectasia.

Bipolar:

Pinpoint, precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K251813 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251813: CURIS II RF Generator (REF 360100-05).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251813

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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