Device
The Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into...
Manufacturer
TAEWOONGMEDICAL.CO.,LTD
Model: OCT1908 Catalog: OCT1908 DI: 08809909421716 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-27 Current Version: 2026-05-05
Description
The Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 67e22b15-d22e-4dee-aade-7e64fa1f4f80
Distribution Status: In Commercial Distribution
DUNS Number: 689484322
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08809909421716
Type: Primary
Issuing Agency: GS1
GMDN
Code: 61875
Name: Endoscopic electrosurgical electrode, monopolar, single-use
Definition:
A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.
FDA Product Codes
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Premarket Submissions
Submission Number: K223256
Supplement Number: 000