510(k) · Cleared

Recalled · 2008

Reprocessed Guidewires

K012556510(k) TraditionalCleared Apr 29, 2002264-day reviewClass II21 CFR 876.5010Recalls 1

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

Sterilmed, Inc. · NML Catheter, Biliary, Reprocessed

Cleared on Apr 29, 2002 as substantially equivalent to K922302 (Boston Scientific Corp, 1992) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 1993. It has been recalled once.

Decided: Apr 29, 2002
Review: 264 days
Class: Class II
Product code: NML
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K931650 (1993). 4 ancestors in all, the oldest K922302 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK931650 Microvasive Insurg Geenen CBD Guide WireBoston Scientific Corp · 1993
1 generation backK964955 Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…Flexmedics · 1997
This deviceK012556 Reprocessed GuidewiresSterilmed, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K931650	Microvasive Insurg Geenen CBD Guide Wire	Boston Scientific Corp	1993	—
−1	K964955	Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…	Flexmedics	1997	—
0 (this device)	K012556	Reprocessed Guidewires	Sterilmed, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	1	0

FIG. 1 — Lineage of K012556, 1993–2002Source: 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 NML? 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
*	K922302	Jagwire (TM) Recanalization Guidewire Summary page 5 …ass I, 21CFR §876.5010 & 21CFR §876.1500 Product Code: FGE & KOG Predicate Device(s): The reprocessed guidewire is substantially equivalent to the Jagwire™ guidewire (K922302) manufactured by Microvasive, and the FlexFinder® Guidewire (K964955) manufactured by FlexMedics. Device Description: Reprocesse…	Boston Scientific Corp	1992	—
*	K964955	Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire… Summary page 5 …edicate Device(s): The reprocessed guidewire is substantially equivalent to the Jagwire™ guidewire (K922302) manufactured by Microvasive, and the FlexFinder® Guidewire (K964955) manufactured by FlexMedics. Device Description: Reprocessed guidewires are constructed utilizing a metal alloy that is encapsul…	Flexmedics	1997	—

Also cleared against K922302: 4 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
Aug 8, 2008	Not classified	Z-0558-2009	Packaging process control	SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
None of the 4 ancestors has a recall.
4 other devices also cite its predicate K922302.

How does its category compare?

All NML devices

NML Catheter, Biliary, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NML

FDA has decided no NML device since 2007.

Median 510(k) review, days · NML

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

Recalls per year · NML

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · NML

1in 2009

2007high 1 (2009) · low 0 (2007)2025

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

View these four charts as a table

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

What is it indicated for?

Reprocessed guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

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/K012556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012556: Reprocessed Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012556

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026