Pump, Infusion, Ophthalmic

Device Code: 4133

Product Code(s): MRH

Device Classification Information

• Device Type ID: 4133
• Device Name: Pump, Infusion, Ophthalmic
• Regulation Description: Infusion Pump.
• Regulation Medical Specialty: General Hospital
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Diagnostic And Surgical Devices Branch (DSDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5725 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MRH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 6-273 ISO 23908 First Edition 2011-06-11
  Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling

Total Product Life Cycle

• Device Type ID: 4133
• Device: Pump, Infusion, Ophthalmic
• Product Code: MRH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Infusion Pump.
• CFR Regulation Number: 880.5725 [🔎]

Premarket Reviews
Manufacturer	Decision
SIGHT SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Detachment Of Device Or Device Component	17
Detachment Of Device Component	9
Adverse Event Without Identified Device Or Use Problem	4
Use Of Device Problem	2
Improper Or Incorrect Procedure Or Method	2
Catheter	1
No Apparent Adverse Event	1
Cannula	1
Material Fragmentation	1
Total Device Problems	38

TPLC Last Update: 2019-04-02 20:43:34