Who is the manufacturer of PERCUTANEOUS INTRODUCER SYSTEM?

Boston Scientific Corp filed the 510(k) submission for PERCUTANEOUS INTRODUCER SYSTEM (K961219).

What is the FDA product code for PERCUTANEOUS INTRODUCER SYSTEM?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PERCUTANEOUS INTRODUCER SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PERCUTANEOUS INTRODUCER SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PERCUTANEOUS INTRODUCER SYSTEM

K961219 · Boston Scientific Corp · GEH · Jun 21, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961219
Device Name	PERCUTANEOUS INTRODUCER SYSTEM
Applicant	Boston Scientific Corp
Product Code	GEH · General, Plastic Surgery
Decision Date	Jun 21, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2

Intended Use

The proposed kit is indicated for suprapubic bladder drainage and percutaneous access for the placement of thermosensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems.

Device Story

Percutaneous Introducer System kit; includes guidewires, access needles, dilators, drainage catheter with connecting tube, scalpel, and syringe. Used by clinicians during ultrasound-guided urological cryosurgery. Facilitates suprapubic bladder drainage and placement of thermosensor probes. Provides percutaneous access to target site. Enables monitoring during cryosurgical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Kit components: guidewires, needles, dilators, drainage catheter, connecting tube, scalpel, syringe. Mechanical device; no energy source or software.

Indications for Use

Indicated for suprapubic bladder drainage and percutaneous access for thermosensor probe placement in patients undergoing ultrasound-guided urological cryosurgery.

Regulatory Classification

Identification

(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

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K961371 — SUBCUTANEOUS URINARY DIVERSON STENT SET · Cook Urological, Inc. · Jul 24, 1996
K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe · Cook Incorporated · Oct 19, 2017

Submission Summary (Full Text)

{0} 06/17/96 12:14 508 650 8935 3SC REG. DEPT. 005 Boston Scientific Corporation January 10, 1996 JUN 21 1996 510(k) Premarket Notification Percutaneous Introducer System # FOI RELEASABLE K961219 # 510(K) Summary Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification". . . adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness. Date: January 10, 1996 Owner Operator Submitting this Premarket Notification: Boston Scientific Corporation 480 Pleasant Street Watertown, MA 02172 (508) 650-8000 Contact Person: Lorraine M. Hanley Project Manager, Regulatory Affairs Device Common Name: Percutaneous Introducer System Device Trade Name: To be Determined Classification Name: Boston Scientific Corporation believes that the Percutaneous Introducer System is best described by the following device classification names: Catheter Introducer: Class II, CFR 870.1340 Introducer/Drainage Catheter and Accessories Class I, 21 CFR 878.4200 ## Device Description & Intended Use: The kit is comprised of guidewire(s), access needles(s), dilator(s), drainage catheter with connecting tube, scalpel and syringe. The proposed kit is indicated for suprapubic bladder drainage and percutaneous access for the placement of thermosensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems. ## Substantial Equivalence: All components of the proposed kit are either legally marketed preamendment devices, exempt form 510(k) Premarket Notification or have been found to be substantially equivalent through the 510(k) process for the uses for which the kit is intended. ## Conclusions: Based on the information presented in this current premarket notification, Boston Scientific Corporation believes that the proposed Percutaneous Introducer System is safe and effective, that it will meet the minimum requirements that are considered acceptable for its intended use, and that a determination of "substantial equivalence" is supported.