# K961219: Percutaneous Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 21, 1996 after 85 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jul 22, 2005 · Not classified · Z-1462-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1468-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1463-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1470-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1520-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1521-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1466-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1465-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1469-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1471-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1522-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1519-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1464-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1461-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1467-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

## Indications for use
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.

Source page: https://510kreport.com/device/K961219
Methodology: https://510kreport.com/methodology