510(k) Report

510(k) · Cleared

Cleared

Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff

K150927510(k) TraditionalCleared May 27, 201551-day reviewClass II21 CFR 876.1500

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

Coloplast A/S · OCY Endoscopic Guidewire, Gastroenterology-Urology

Cleared on May 27, 2015 as substantially equivalent to K131072 (Coloplast A/S, 2013) after a 51-day review. Its family tree reaches back 2 generations to 1992.

Decided
May 27, 2015
Review
51 days
Class
Class II
Product code
OCY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K923607 (1992). No later device cites it as a predicate yet.

K923607 · Radifocus Guide Wire M · Terumo Medical Corp. · 1992K131072 · Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic · Coloplast A/S · 2013199019952000200520102015
K131072 · Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic · Coloplast A/S · 2013K923607 · Radifocus Guide Wire M · Terumo Medical Corp. · 19920
  1. Root · 2 generations backK923607 Radifocus Guide Wire MTerumo Medical Corp. · 1992
  2. 1 generation backK131072 Orchestra Hydrophilic Guidewire Standard Angled, Orchestra…Coloplast A/S · 2013
  3. This deviceK150927 Orchestra Hydrophilic Guidewire standard angled, Orchestra…Coloplast A/S · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K923607Radifocus Guide Wire MTerumo Medical Corp.1992—
−1K131072Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic…Coloplast A/S2013—
0 (this device)K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic…Coloplast A/S2015—
FIG. 1 — Lineage of K150927, 1992–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OCY? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K131072Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire…
Summary page 5
…philic Guidewire is substantially equivalent in performance, indication, design and materials to Orchestra® Hydrophilic Guidewire, cleared under Premarket notification # K131072. Summary and Conclusions from the Nonclinical Tests Submitted: Merit modified the proportion of constituents in the hydrogel co…
Coloplast A/S2013—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 20.8 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All OCY devices

OCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OCY

1in 2016

2007: 12008: 32009: 12012: 22013: 42014: 52015: 32016: 1
2007high 5 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCY

51in 2015

2008: 55 days median2013: 60 days median2014: 41 days median2015: 51 days median
2007high 60 (2013) · low 41 (2014)2026

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

Recalls per year · OCY

8in 2019

2019: 8
2007high 8 (2019) · low 0 (2007)2026

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

Adverse event reports per year · OCY

133in 2025

2007: 32008: 72009: 72010: 92011: 32012: 12013: 322014: 512015: 2832016: 1582017: 852018: 1012019: 1032020: 1282021: 942022: 1342023: 1152024: 1312025: 133
2007high 283 (2015) · low 1 (2012)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—03
200835507
20091—07
20100—09
20110—03
20122—01
2013460032
2014541051
20153510283
20161—0158
20170—085
20180—0101
20190—8103
20200—0128
20210—094
20220—0134
20230—0115
20240—0131
20250—0133
20260—0—

What is it indicated for?

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

Indications for use as stated in the FDA summary.

More from Coloplast A/S

71 FDA decisions under this applicant name. See the company

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K220420Saffron Fixation SystemColoplast A/S · 2022
  • K191536Biatain Silicone AgColoplast A/S · 2020
  • K181811ReTrace Ureteral Access SheathColoplast A/S · 2018
  • K173527Digitex Delivery DeviceColoplast A/S · 2018

Recent decisions in OCY

The OCY category page

  • K153264EasyPass GuidewireMedi-Globe Corporation · 2016
  • K151471Radifocus Glidewire Endoscopic WireTerumo Medical Corporation · 2015
  • K150225NovaGold High Performance GuidewireNeometrics, Inc. · 2015
  • K142950Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc. · 2014
  • K141820Jagwire High Performance GuidwireBoston Scientific Corp · 2014

https://510kreport.com/device/K150927 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150927: Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150927

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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