Who is the manufacturer of DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE?

United States Endoscopy Group, Inc. filed the 510(k) submission for DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (K962676).

What is the FDA product code for DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE?

FGO. It is classified under 21 CFR 876.4680 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE?

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

Who can help prepare an FDA 510(k) submission like DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE?

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.

DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE

K962676 · United States Endoscopy Group, Inc. · FGO · Oct 4, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K962676
Device Name	DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
Applicant	United States Endoscopy Group, Inc.
Product Code	FGO · Gastroenterology, Urology
Decision Date	Oct 4, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4680
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.

Device Story

Endoscopic retrieval device; used by physicians during flexible endoscopy; enables grasping and removal of foreign bodies, polyps, tissue, or calculi from GI or biliary tracts. Device consists of a retrieval basket introduced through an endoscope; basket placed around target object for extraction. Facilitates minimally invasive removal; reduces need for more invasive surgical interventions. Physician determines patient appropriateness based on clinical assessment.

Clinical Evidence

No clinical data provided. Safety and effectiveness based on long-term clinical history of retrieval basket technology and adherence to established manufacturing and sterilization standards.

Technological Characteristics

Retrieval basket instrument for flexible endoscopy. Materials certified to appropriate standards. Quality assurance per MIL-STD-9858. Sterilization via ETO gas per AAMI standards.

Indications for Use

Indicated for patients requiring removal of foreign bodies, tissue, polyps, stones, or calculi from the gastrointestinal or biliary tract via flexible endoscopy. Contraindicated in patients with uncooperative status, perforated viscus, large biliary stones, or general contraindications to endoscopy, or when the risk of removal exceeds the endoscopic procedure risk.

Regulatory Classification

Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Related Devices

K961611 — OLYMPUS BASKET GRASPERS (UROLOGY) · Olympus America, Inc. · Jul 18, 1996
K974300 — TELEMED SYSTEMS RETRIEVAL BASKET · Telemed Systems, Inc. · Dec 19, 1997
K120084 — ENDOSCOPIC RETRIEVAL DEVICE · United States Endoscopy Group, Inc. · May 30, 2012
K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR · Telemed Systems, Inc. · Jan 21, 1998
K182909 — Roth Net Retriever Product Line · United States Endoscopy Group, Inc. · Nov 21, 2018

Submission Summary (Full Text)

{0} OCT 4 1996 K962676 ## SECTION II ## 510(k) Summary of SAFETY AND EFFECTIVENESS ## U.S.E. ENDOSCOPIC RETRIEVAL DEVICES (all versions) SUMMARY The Summary of Safety and Effectiveness on the endoscopic procedure for retrieval of foreign bodies, tissue or polyps, stones or calculi used reflects data available and present at the time the summary was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth. ## Procedure/Product Overview Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods. The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years. ## Contraindications for retrieval of foreign body, tissue or polyp, stones or calculi Retrieval via flexible endoscopy is contraindicated in the following cases: 1) If the risk or removal of the object is greater than the endoscopic procedure. 2) Uncooperative patient 3) Any contraindication to performing endoscopy 4) Known or suspected perforated viscus 5) Presence of large stones in biliary tract and other associated contraindications for therapeutic biliary procedures. The physician will determine patient’s appropriateness for procedure. ## Manufacturing Overview U.S.E. designs, manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices. U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications. Materials used in the manufacturing process are certified to standards appropriate for their use. ## Sterility Testing The Endoscopic Retrieval Devices will be sterilized using ETO gas and the methods will conform to AAMI standards for sterilization of medical devices. {1} K962676 p 2 of 2 # Bibliography Hardick, Marcia and Beck, Marjorie (Editors), *Manual of Gastrointestinal Procedures*, (2nd Edition). New York: Society of Gastroenterology Nurses and Associates, Inc., 1989. Ravenscroft, M.M. and Swan, C.H.J. *Gastrointestinal Endoscopy and Related Procedures*. Baltimore: Williams & Wilkins, 1984. Berci, George *Endoscopy*. New York: Appleton-Century-Crofts, 1976.