Padlock Clip

Basic Information

• Brand Name: Padlock Clip
• Primary DI: 00724995226732
• Version / Model: 00713229
• Catalog Number: 00713229
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-31
• Public Version: 3
• Public Version Date: 2025-06-04
• Public Version Status: Update
• Public Device Record Key: 7d1fec18-53c8-45be-a529-474a76836ab3

Device Description

The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and TouchSoft Coagulator Probe. It is designed for use in a flexible endoscope intended for the diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDI	SNARE, FLEXIBLE	Gastroenterology, Urology	876.4300	2
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	Gastroenterology, Urology	876.4300	2
PKL	Hemostatic metal clip for the GI tract	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	No	Active
61208	Gastrointestinal endoscopic clip, long-term, non-bioabsorbable	A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.	Yes	Active
61877	Inert gas-enhanced endoscopic electrosurgical electrode, reusable	An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995226732	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240274	000
K250842	000

Device Sizes

Type	Value	Unit	Text
Length	230	Centimeter
Outer Diameter	2.4	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry