RETRIEVAL SNARE

K963750 · Boston Scientific Corp · FGO · Nov 22, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963750
• Device Name: RETRIEVAL SNARE
• Applicant: Boston Scientific Corp
• Product Code: FGO · Gastroenterology, Urology
• Decision Date: Nov 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.

Device Story

Retrieval Snare is a flexible endoscopic instrument used for grasping and removing foreign bodies from the alimentary tract. Device consists of a catheter with a distal loop and a proximal three-ring plastic handle. Operator (physician) advances catheter through an endoscope to the target site; manipulates handle to open/close the loop around the foreign body; secures the object for withdrawal. Used in clinical settings (endoscopy suites). Benefits include minimally invasive removal of objects like stents or wires, reducing need for more invasive surgical intervention.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flexible catheter with distal loop and proximal three-ring plastic handle. Loop diameters: 11-33 mm. Loop shapes: Oval, Crescent, or Hexagonal. Sheath outer diameters: 1.9 mm or 2.3 mm. Usable length: 180 cm. Mechanical operation via manual handle manipulation.

Indications for Use

Indicated for grasping and retrieval of foreign bodies (e.g., guidewires, pullwires, plastic stents) within the alimentary tract. No specific age or gender restrictions; no known contraindications.

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.

Predicate Devices

• BSC's Snare (K950496)
• BSC's Profile Polypectomy Snare (K941750)
• BSC's Retrieval Loop (K860269)

Submission Summary (Full Text)

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NOV 22 1996
K963750
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SECTION 8
510(K) SUMMARY

# FOI RELEASABLE

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.

- COMMON/USUAL NAMES: Snare, Flexible
- TRADE/PROPRIETARY NAME: Retrieval Snare
- CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II
| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Snare, Flexible | 78 FDI | 876.4300 |
- DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU) Gastro Renal (GRDB)
- OWNER/OPERATOR: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760
- CONTACT PERSON: Lisa M. Quaglia, Regulatory Affairs Specialist

# INDICATIONS FOR USE

The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.

# CONTRAINDICATIONS

There are no known contraindications for this device.

# POTENTIAL COMPLICATIONS

Possible complications include, but may not be limited to: inadvertent perforation during retrieval.

Premarket Notification, Retrieval Snare, November 20, 1996
Premarket Notification, Retrieval Snare, November 20, 1996

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11/20/96 15:43 508 650 8935 BSC REG DEPT 011
K963750
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FIGURE 8-1: SIMILARITIES AND DIFFERENCES BETWEEN RETRIEVAL SNARE, BOSTON SCIENTIFIC'S SNARE, PROFILE POLYPECTOMY SNARE, AND RETRIEVAL LOOP

| | Microvasive Retrieval Snare
(This 510(k)) | BSC's Snare
(K950496) | BSC's Profile Polypectomy Snare
(K941750) | BSC's Retrieval Loop
(K860269) |
| --- | --- | --- | --- | --- |
| USE | | | | |
| Indication | Retrieval of foreign body such as guidewires, pullwires, or plastic stents. | Resection, removal and cauterization of structures such as polyps, tissue, lesions or small tumors. | Removal and cauterization of sessile, diminutive, and pedunculated polyps. | Removal of foreign bodies, stones, PEG tubes, and stents. |
| Catheter | | | | |
| Usable Length (cm) | 180 | 40 to 240 | 240 | 190 |
| Sheath OD (mm) | 1.9 or 2.3 | 1.9 or 2.3 | 1.9 | 1.7 |
| | | | | |
| Handle Type | Plastic Three-Ring | Plastic Three-Ring | Plastic Three-ring | Plastic Three-Ring |
| Loop Diameter | 11 - 33 mm | 11 - 33 mm | 11-33 mm | 3/8" |
| Loop Shapes | Oval, Crescent, or Hexagonal | Oval, Crescent, or Hexagonal | Oval, Crescent, or Hexagonal | Oval |

BSC = Boston Scientific Corporation

Premarket Notification, Retrieval Snare, November 20, 1996 31