Devices

Device Recall Olympus SD Snares

Model / Serial
Snare Package Lot numbers: 9YK, 9ZK, 01K, 02K, & 03K. Snare Tube Lot Numbers: K9Y10, K9Y16, K9Y18, K9Y19, KDY20, K9Y24, K9Y25, K9Y26, K9Y27, K9Y30,K9Z01, K9Z02, K9Z03, K9Z04, K9Z07, K9Z08, K9Z09, K9Z10, K9Z11, K9Z14,K9Z15, K9Z16, K9Z17, K9Z18, K9Z21, K9Z22, K9Z24, K9Z25, K9Z28, K9Z29, K0105, K0106, K0107, K0108, K0112, K0113, K0114, K0115, K0118, K0119, K0120, K0121, K0122, K0127, K0129, K0202, K0203, K0204, K0205, K0208, K0209, K0210, K0212, K0215, K0216, K0217, K0218, K0222, K0224,K0225, K0226, K0301, K0302, K0303, K0305, K0308, K0309, K0310, K0311, K0312, K0315, and K0316.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.
Product Description
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. || To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
Manufacturer
Olympus America Inc.
1 Event
- Recall of Device Recall Olympus SD Snares

Manufacturer

Olympus America Inc.

Manufacturer Address
Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA

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