APOLLO3

Basic Information

• Brand Name: APOLLO3
• Primary DI: 00653405051575
• Version / Model: 007106
• Catalog Number: 007106
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 4f169148-3503-46b0-88d3-255d43c956ae
• Distribution End Date: 2020-10-21

Device Description

APOLLO3 Papillotome, Triple Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00653405051575	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982557	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.889	Millimeter
Device Size Text, specify			20 Millimeter Tip Length
Outer Diameter	0.035	Inch
Device Size Text, specify			7 - 5 French Catheter Gauge Outer Diameter
Device Size Text, specify			20 Millimeter Cutting wire Length
Device Size Text, specify			2.3 - 1.7 Millimeter Catheter Gauge Outer Diameter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 16 – 27 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: High: 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit