Who is the manufacturer of A.S.D. SAFETY TROCAR?

American Surgical Devices filed the 510(k) submission for A.S.D. SAFETY TROCAR (K955412).

What is the FDA product code for A.S.D. SAFETY TROCAR?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for A.S.D. SAFETY TROCAR?

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

What are the predicate devices for A.S.D. SAFETY TROCAR?

ENDOPATH EP SURGICAL TROCAR; U.S. Surgical SURGIPORT.

Who can help prepare an FDA 510(k) submission like A.S.D. SAFETY TROCAR?

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.

A.S.D. SAFETY TROCAR

K955412 · American Surgical Devices · HET · May 14, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K955412
Device Name	A.S.D. SAFETY TROCAR
Applicant	American Surgical Devices
Product Code	HET · Obstetrics/Gynecology
Decision Date	May 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

Intended Use

The A.S.D. Surgical Trocar is intended for use during vascular and gynecological laparoscopy and other abdominal procedures, to create an entry point for laparoscopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula.

Device Story

Single-use, sterile, disposable trocar; creates entry point for laparoscopic instruments into abdominal cavity. Components: obturator with pyramidal tip; spring-loaded safety shield; radiolucent cannula with gasket system; stability thread. Optional obturator adapter allows 5mm instrument use in 10/11mm systems. Used in OR by surgeons; provides stable access port; maintains pneumoperitoneum via gasket. Benefits: facilitates minimally invasive surgery; ensures safe instrument guidance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: aluminum, stainless steel, polycarbonate, silicone rubber. Design: obturator with pyramidal tip, spring-loaded safety shield, radiolucent cannula, gasket system, stability thread. Sizes: 10/11mm (100mm/150mm length) and 5mm (70mm/100mm length). Sterilization: sterile, single-use.

Indications for Use

Indicated for patients undergoing vascular, gynecological, or other abdominal laparoscopic procedures requiring instrument access to the abdominal cavity. Contraindicated when endoscopic techniques are contraindicated.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

ENDOPATH EP SURGICAL TROCAR
U.S. Surgical SURGIPORT

Related Devices

K142547 — Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm · Covidien · Dec 9, 2014
K202931 — Disposable Trocar · Wuxi Shukang Medical Appliance Co., Ltd. · Nov 17, 2020
K974763 — DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA · Deroyal Industries, Inc. · Jul 10, 1998
K971738 — ENDOPATH RESPOSABLE TROCAR SYSTEM · Ethicon Endo-Surgery, Inc. · Aug 7, 1997
K172038 — Trocar · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · Oct 27, 2017

Submission Summary (Full Text)

{0} APPENDIX 8 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Company: American Surgical Device 41917 Osgood Road Fremont, CA 94539 Medical Device Establishment Registration #: pending Contact: Ms. Liza Burns, Regulatory Consultant Trade Name: A.S.D. Safety Trocar Common Name: Surgical Disposable Trocar Classification Name: Trocar, Gastro-Urology Classification Code: Gastroenterology and Urology 78FBQ Device Description: The A.S.D. Surgical Trocar is a single-use, sterile, temporary, disposable device intended for use during laparoscopy, to create an entry point for laparoscopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula. The Trocar consists of: 1) an obturator with a pointed pyramidal tip, 2) a spring-loaded safety shield to cover the tip of the obturator after tissue penetration, 3) a radiolucent cannula (sleeve) with a gasket system to prevent leakage of gas during insertion and withdrawal of instruments 4) an accessory stability thread to help secure the cannula in the body during use. An optional accessory, an obturator adapter is available to be used as a reducer with the 10/11mm system. When the adapter is used, 5 mm instruments are accepted into the 10/11mm trocar. The A.S.D. Trocar is available in the 10/11mm and 5mm sizes. The size of the trocar corresponds to the size of the instrument that can be entered in the trocar. The sleeve lengths available for the 10/11mm are 100 mm and 150mm; and for the 5mm trocar are 70 mm and 100mm. The stability threads are available in 38 mm and 51 mm lengths. The A.S.D. Trocar is made of aluminum, stainless steel, polycarbonate and silicone rubber. Indications for use: The A.S.D. Surgical Trocar is intended for use during vascular and gynecological laparoscopy and other abdominal procedures, to create an entry point for laparoscopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula. Contraindications: The A.S.D. Trocar in not intended for use when endoscopic techniques are contraindicated. Substantially Equivalent Devices: 1) The ENDOPATH EP SURGICAL TROCAR 2) The U.S. Surgical SURGIPORT Distributed and Manufactured by: American Surgical Devices 41917 Osgood Road Fremont, CA 94539 Tel: 510-252-9999