510(k) · Cleared

Cleared

Olympus CD-6C-1 Coagulation Electrode

K971328510(k) TraditionalCleared Jul 1, 199782-day reviewClass II21 CFR 876.4650

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

Olympus America, Inc. · FFE System, Water Jet Catheter, Renal

Cleared on Jul 1, 1997 as substantially equivalent to K955247 (Olympus America, Inc., 1996) after an 82-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.

Decided: Jul 1, 1997
Review: 82 days
Class: Class II
Product code: FFE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955247 (1996). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955247 Olympus KD Series SphincterotomeOlympus America, Inc. · 1996
This deviceK971328 Olympus CD-6C-1 Coagulation ElectrodeOlympus America, Inc. · 1997
Descendant · cites it directly · 3 of its ownK120909 EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012
Descendant · 2 generations on · 1 of its ownK183240 Empower RF CatheterBroncus Medical, Inc. · 2019
Descendant · 3 generations on · 0 of its ownK200702 EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK170296 CoreCath 2.7SMedtronic Advanced Energy · 2017

Most influential descendants

Showing 4 of 4 · See all

K120909EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012 · cites it directly3descendants
K183240Empower RF CatheterBroncus Medical, Inc. · 2019 · 2 generations on1descendant
K200702EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021 · 3 generations on0descendants
K170296CoreCath 2.7SMedtronic Advanced Energy · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955247	Olympus KD Series Sphincterotome	Olympus America, Inc.	1996	—
0 (this device)	K971328	Olympus CD-6C-1 Coagulation Electrode	Olympus America, Inc.	1997	—
+1	K120909	EC 2.7 Endoscopic Cutter	Medtronic Advanced Energy, LLC	2012	—
+2	K183240	Empower RF Catheter	Broncus Medical, Inc.	2019	—
+3	K200702	EasyPath RF Introducer Sheath	Broncus Medical, Inc.	2021	—
+2	K170296	CoreCath 2.7S	Medtronic Advanced Energy	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2017	1	0
2019	1	0
2021	1	0

FIG. 1 — Lineage of K971328, 1996–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FFE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K955247	Olympus KD Series Sphincterotome Summary page 1 …0, Class I1 Endoscopic Coagulation Electrode and Accessories. Predicate Devices: Olympus CD-1L/U Coagulation Electrode (Preamendment) Olympus KD Series Sphinctertomes (K955247) Prepared & Submitted By: Mr. Subhash Patel (Contact Person) Olympus America Inc. Endoscope Division Two Corporate Center Drive…	Olympus America, Inc.	1996	—
*	—	Olympus CD-1L/U Coagulation Electrode (Preamendment) Named without a submission number			—

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K120909	EC 2.7 Endoscopic Cutter	Medtronic Advanced Energy, LLC	2012	3

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?

Its one ancestor has no recall.
Of its descendants, K120909 (Medtronic Advanced Energy, LLC, 2012) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FFE devices

FFE System, Water Jet Catheter, Renal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFE

FDA has decided no FFE device since 2007.

Median 510(k) review, days · FFE

Too few FFE 510(k)s in any year since 2007 to give a median.

Recalls per year · FFE

No recall names FFE since 2007.

Adverse event reports per year · FFE

1in 2015

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code FFE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	1
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971328 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971328: Olympus CD-6C-1 Coagulation Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971328

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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