510(k) · Cleared
ClearedIntercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgi-Vision, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on May 21, 2002 as substantially equivalent to K994436 (Surgi-Vision, Inc., 2000) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 21, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K952232 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK952232 Mrinnervu Disposable Endorectal Colon Coil, Catalong NO. PCC-15Medrad, Inc. · 1995
- 2 generations backK992193 Endo-Esophageal MR CoilSurgi-Vision, Inc. · 1999
- 1 generation backK994436 Surgi-Vision Esophageal Stylet CoilSurgi-Vision, Inc. · 2000
- This deviceK020790 Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil…Surgi-Vision, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952232 | Mrinnervu Disposable Endorectal Colon Coil, Catalong NO. PCC-15 | Medrad, Inc. | 1995 | — |
| −2 | K992193 | Endo-Esophageal MR Coil | Surgi-Vision, Inc. | 1999 | — |
| −1 | K994436 | Surgi-Vision Esophageal Stylet Coil | Surgi-Vision, Inc. | 2000 | — |
| 0 (this device) | K020790 | Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and… | Surgi-Vision, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K994436 | Surgi-Vision Esophageal Stylet CoilSummary page 1…al Internal MR Coil is substantially equivalent to the Surgi-Vision Esophageal Stylet Coil, which was cleared for marketing on March 14, 2000, in premarket notifications K994436. The Intercept™ Urethral Microcoil, is substantially equivalent to the Intercept Urethral Microcoil, which was cleared for market… | 2000 |
| * | K011781 | Intercept-Urethral Microcoil | 2001 |
| * | K003436 | Surgi-Vision Guidewire CoilSummary page 1…rcept™ Vascular Internal MR Coil is substantially equivalent to the Surgi- Vision Guidewire Coil, and cleared for marketing on February 2, 2001 in premarket notification K003436. This submission also represents notification of the change from SV coils to Intercept Coils. The predicate devices are compatibl… | 2001 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K994436.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the…
Read the full statement (229 words)
The Intercept™ Urethral Internal MR Coil is recommended for
high-resolution Magnetic Resonance Imaging of the male and female
urethra and surrounding tissue. The single use, disposable coil was
designed to be inserted in the urethra of a patient during MRI scans in
order to obtain improved image quality in the anatomical regions
surrounding the urethra and including the prostate in males. The
flexible coil facilitates placement of the coil in the anatomy. This
product is to be used with a 1.5T Philips MR! system. The signals
picked up by the coil are conducted through a small coaxial cable to a
connection with the standard surface coil connector for MRl systems.
The coil and cable are completely sealed inside the insulating layer.
The Intercept™ Vascular Internal MR Coil is recommended for
high-resolution Magnetic Resonance Imaging of the peripheral vasculature.
The single use, disposable coil is designed for insertion into an artery or
vein of a patient during MRI scans in order to obtain improved image
quality in the peripheral vasculature. The flexible coil facilitates placement
of the coil in the peripheral vascular anatomy. The coil would most
commonly be used through femoral artery access similar to .035"
guidewires currently in use. The handling characteristics of this device are
familiar to vascular interventionalists thereby facilitating integration into
their practices.
This product is to be used with a 1.5T Philips MRI system.
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/K020790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020790: Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020790
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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