510(k) · Cleared

Recalled · Class II · 2015

Sureflex Lithotripsy Laser Fibers

K140679510(k) TraditionalCleared Jun 20, 201494-day reviewClass II21 CFR 878.4810Recalls 2

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

American Medical Systems · GEX Powered Laser Surgical Instrument

Cleared on Jun 20, 2014 as substantially equivalent to K050108 (Innovaquartz, 2005) after a 94-day review. Its family tree reaches back 1 generation to 2005. It has been recalled 2 times.

Decided: Jun 20, 2014
Review: 94 days
Class: Class II
Product code: GEX
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K050108 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK050108 Sureflex and Accuflex Laser Lithotripsy FibersInnovaquartz · 2005 · Recalled
This deviceK140679 Sureflex Lithotripsy Laser FibersAmerican Medical Systems · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050108	Sureflex and Accuflex Laser Lithotripsy Fibers	Innovaquartz	2005	6
0 (this device)	K140679	Sureflex Lithotripsy Laser Fibers	American Medical Systems	2014	—

FIG. 1 — Lineage of K140679, 2005–2014Source: 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 GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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
*	K050108	Sureflex and Accuflex Laser Lithotripsy Fibers Summary page 5 …nt for use in general and plastic surgery and in dermatology Classification: 21 CFR § 878.4810 Product Code: GEX Predicate Device: SureFlex™ Lithotripsy Laser Fibers K050108 Device Description: The SureFlex™ Lithotripsy Laser Fiber (SureFlex fiber) is a fiber optic laser delivery device consisting of…	Innovaquartz	2005	6

Also cleared against K050108: 6 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 28, 2015	Class II	Z-2162-2015	Reprocessing Controls	validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new…
May 28, 2015	Class II	Z-2163-2015	Reprocessing Controls	validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
6 other devices also cite its predicate K050108.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

General SureFlex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). SureFlex is designed primarily for holmium…

Read the full statement (214 words)

General

SureFlex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). SureFlex is designed primarily for holmium (Ho:YAGS) lasers, but may be used with any laser wavelength between 500nm and 2200nm that has been cleared for surgical use, e.g. Nd:YAG, KTP, Alexandrite, Argon, Ruby, Diode

Specific, by Surgical Specialty (most common use first)

Urology -

Urinary Lithotripsy including but not limited to endoscopic and laparoscopic fragmentation, ablation and vaporization of urinary calculi found from the lower pole of the kidney to the urethra and distal impacted fragments of steinstrasse.

Urological Surgery (vaporization, coagulation, hemostasis, excision and incision of soft tissue) including, but not limited to open, endoscopic and laparoscopic surgery for the removal of superficial and invasive bladder tumors and lesions, including condylomas, treatment of ureteral strictures obstructions, polyps, vascularities and hemangioma as well as prostatectomy (BPH).

Gastroenterology -

Laser-based surgical procedures including, but not limited to open, endoscopic and laparoscopic gastroenterological surgery for ablation, vaporization, fragmentation, coagulation, hemostasis, incision, excision, resection, and hemostasis of biliary calculi, lesions, neoplasms, polyps, ulcers, tears, erosions and tumors.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K140679 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140679: Sureflex Lithotripsy Laser Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140679

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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