510(k) · Cleared

Cleared

Saline Enhanced Electrosurgical Resection (Seer) Device

K082568510(k) TraditionalCleared Nov 17, 200874-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

Bovie Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 17, 2008 as substantially equivalent to K014260 (Tissuelink Medical, Inc., 2002) after a 74-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.

Decided: Nov 17, 2008
Review: 74 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K014260 (2002). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK014260 Tissuelink Solid Cylinder Monopolar DeviceTissuelink Medical, Inc. · 2002 · Recalled
This deviceK082568 Saline Enhanced Electrosurgical Resection (Seer) DeviceBovie Medical · 2008
Descendant · cites it directly · 2 of its ownK121678 DTADGyrus Acmi, Inc. · 2012
Descendant · 2 generations on · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
Descendant · 3 generations on · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
Descendant · cites it directly · 0 of its ownK091440 Laparoscopic Resection Device, Model SR326LBovie Medical · 2009

Most influential descendants

Showing 4 of 4 · See all

K121678DTADGyrus Acmi, Inc. · 2012 · cites it directly2descendants
K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · 2 generations on1descendant
K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022 · 3 generations on0descendants
K091440Laparoscopic Resection Device, Model SR326LBovie Medical · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K014260	Tissuelink Solid Cylinder Monopolar Device	Tissuelink Medical, Inc.	2002	1
0 (this device)	K082568	Saline Enhanced Electrosurgical Resection (Seer) Device	Bovie Medical	2008	—
+1	K121678	DTAD	Gyrus Acmi, Inc.	2012	—
+2	K123429	Olympus Energy Power System (Eps)	Gyrus Acmi, Inc.	2013	12
+3	K212650	Celeris, Disposable Sinus Debrider	Gyrus Acmi, Inc.	2022	—
+1	K091440	Laparoscopic Resection Device, Model SR326L	Bovie Medical	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2013	1	0
2022	1	0

FIG. 1 — Lineage of K082568, 2002–2022Source: 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
*	K014260	Tissuelink Solid Cylinder Monopolar Device Summary page 2 …Page 2 === 510(k) SUMMARY (per CFR21 807.92(c)) DEVICE DESCRIPTION: Predicate Devices: TissueLink: Solid Cylinder Monopolar Device K014260 INTENDED USE: The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an…	Tissuelink Medical, Inc.	2002	1

Also cleared against K014260: 1 other device →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K121678	DTAD	Gyrus Acmi, Inc.	2012	2
K091440	Laparoscopic Resection Device, Model SR326L	Bovie Medical	2009	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?

Its one ancestor has a recall.
Of its descendants, K121678 (Gyrus Acmi, Inc., 2012) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K014260.

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. 2008, 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 Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082568: Saline Enhanced Electrosurgical Resection (Seer) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082568

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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