510(k) · Cleared
Recalled · 2005Percutaneous Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · GEH Unit, Cryosurgical, Accessories
Cleared on Jun 21, 1996 after an 85-day review. The FDA summary names no predicate by number. It has been recalled 15 times.
- Decided
- Jun 21, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 15
- Predicates
- 0
The FDA summary names no predicate by number.
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 GEH? 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 GEH device
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- #2 Held for the reportin the report
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What was it cleared against?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|---|
| Jul 22, 2005 | Not classified | Z-1462-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1468-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1463-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1470-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1520-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1521-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1466-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1465-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1469-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1471-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1522-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1519-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1464-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1461-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
| Jul 22, 2005 | Not classified | Z-1467-05 | Other | The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, 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 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The proposed kit is indicated for suprapubic bladder drainage and percutaneous access for the placement of therminsensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems.
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/K961219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961219: Percutaneous Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961219
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026