510(k) · Cleared

Cleared

Thermal Coagulator

K870705510(k) TraditionalCleared Apr 17, 198756-day reviewClass II21 CFR 876.4300

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

Microvasive · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Apr 17, 1987 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.

Decided: Apr 17, 1987
Review: 56 days
Class: Class II
Product code: KNS
Recalls: None
Predicates: 0

62 later devices descend from it, 1 citing it directly.

This deviceK870705 Thermal CoagulatorMicrovasive · 1987
Descendant · cites it directly · 61 of its ownK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
Descendant · 2 generations on · 46 of its ownK023288 Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003
Descendant · 3 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
Descendant · 3 generations on · 22 of its ownK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2002high 5 (2006) · low 0 (2015)2026

Most influential descendants

Showing 5 of 62 · See all

K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002 · cites it directly61descendants
K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003 · 2 generations on46descendants
K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 3 generations on42descendants
K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · 3 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K870705	Thermal Coagulator	Microvasive	1987	—
+1	K013873	Cobra Cardiac Electrosurgical System	Boston Scientific Corp	2002	—
+2	K023288	Cobra Bipolar Clamp, Model 15902	Boston Scientific EP Technologies	2003	—
+3	K040690	Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…	Cryocath Technologies, Inc.	2004	—
+2	K022894	Epicor Medical Ablation System	Epicor Medical, Inc.	2004	—
+3	K053436	Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and…	Cryocath Technologies, Inc.	2006	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	4	0
2005	1	0
2006	5	0
2007	2	0
2008	5	0
2009	3	0
2010	3	0
2011	3	0
2012	5	0
2013	2	0
2014	5	0
2016	1	0
2018	4	0
2019	4	0
2020	2	0
2021	2	0
2022	2	0
2023	1	0
2024	3	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K870705, 1987–2026Source: 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 KNS? 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 KNS device

#1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (62)

See all 62

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013873	Cobra Cardiac Electrosurgical System	Boston Scientific Corp	2002	61

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, K013873 (Boston Scientific Corp, 2002) has gone furthest, with 61 descendants of its own.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2007high 252 (2015) · low 30 (2016)2026

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

Recalls per year · KNS

14in 2024

2007high 41 (2021) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNS

1,504in 2025

2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, 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	1	—	3	164
2008	3	61	5	587
2009	3	212	2	1,027
2010	4	168	0	908
2011	1	—	2	860
2012	2	—	0	848
2013	2	—	0	449
2014	1	—	0	405
2015	3	252	0	406
2016	3	30	6	457
2017	3	48	1	446
2018	5	62	0	563
2019	7	66	0	668
2020	4	212	0	906
2021	4	139	41	814
2022	3	182	0	913
2023	9	83	0	976
2024	3	198	14	1,533
2025	11	171	0	1,504
2026	2	—	4	—

https://510kreport.com/device/K870705 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870705: Thermal Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870705

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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