Who is the manufacturer of OLYMPUS SD SERIES SNARES?

Olympus America, Inc. filed the 510(k) submission for OLYMPUS SD SERIES SNARES (K955650).

What is the FDA product code for OLYMPUS SD SERIES SNARES?

FDI. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for OLYMPUS SD SERIES SNARES?

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

What are the predicate devices for OLYMPUS SD SERIES SNARES?

Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares; Olympus SD-14/15 sterile disposable snares.

Who can help prepare an FDA 510(k) submission like OLYMPUS SD SERIES SNARES?

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.

OLYMPUS SD SERIES SNARES

K955650 · Olympus America, Inc. · FDI · Mar 29, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K955650
Device Name	OLYMPUS SD SERIES SNARES
Applicant	Olympus America, Inc.
Product Code	FDI · Gastroenterology, Urology
Decision Date	Mar 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract.

Device Story

Reusable electrosurgical snare; used for endoscopic tissue resection in GI tract. Components: proximal control handle, electrical connection cord (A-cord), flexible catheter tube, distal snare loop. Operation: physician positions snare loop around target tissue via slider on control handle; tissue resected via mechanical strangulation combined with electrosurgical current from external generator. Used in clinical/endoscopy settings.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Reusable electrosurgical snare; consists of control handle, A-cord, flexible catheter, and wire loop. Energy source: external electrosurgical generator. Materials: standard medical-grade components for endoscopic use. Sterilization: reusable design requiring standard reprocessing protocols.

Indications for Use

Indicated for endoscopic resection of tissue within the GI tract in patients requiring polypectomy or similar procedures.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares
Olympus SD-14/15 sterile disposable snares

Related Devices

K220846 — CORE-SNARE · Incore Co., Ltd. · Nov 21, 2022
K172734 — Single Use Electrosurgical Snare SD-400 · Olympus Medical Systems Corp. · Dec 7, 2017
K123223 — EC SINGLE USE, POLYPECTOMY SNARE · Endochoice, Inc. · Jan 10, 2013
K213222 — Disposable Polypectomy Snare · Beijing Zksk Technology Co., Ltd. · Jun 6, 2022
K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNARE · Mill-Rose Laboratory · May 23, 1997

Submission Summary (Full Text)

{0} K955650 # 510(k) Summary for Olympus SD Series of Reusable Electrosurgical snares Device Name: Olympus SD snares MAR 29 1996 Common/Usual Name: Snares Classification Name: Endoscope Electrosurgical Unit and Accessories 21 CFR 876.4300 Predicate Devices: Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares and Olympus SD-14/15 sterile disposable snares. Contact Person: Barry Sands Olympus America, Inc. Medical Instrument Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474 Summary Preparation Date: November 10, 1995 Summary Revision Date: February 27, 1996 Statement of Intended Use: The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. Device Description: The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. The SD snares consist of a proximal end control handle, an electrical connection cord (A-cord), a flexible catheter-like tube, and a distal end snare loop. The detachable control handle contains the electrical connections which permit the snare loop to be connected to an electrosurgical generator via the A-cord. The distal end snare loop may be positioned around the target tissue by movement of a slider on the control handle. The tissue is resected by a combination of mechanical strangulation and electrosurgical current.