TPLC - Total Product Life Cycle

• Device: colposcope (and colpomicroscope)
• Product Code: HEX
• Regulation Number: 884.1630
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOP MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
COOPER SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ECLERIS USA
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FORTH PHOTONICS HELLAS SA
	SUBSTANTIALLY EQUIVALENT	1
GYNIUS AB
	SUBSTANTIALLY EQUIVALENT	1
HADLEIGH HEALTH TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ILLUMIGYN LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTECH INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDGYN PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MOBILEODT LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEILER PRECISION MICROSCOPES
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN GOLDCARE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STI MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
STI MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2	2
2019	2	2
2020	1	1
2021	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3	3
Detachment of Device or Device Component	1	1
Malposition of Device	1	1
Material Fragmentation	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	1	1
Abnormal Vaginal Discharge	1	1
No Consequences Or Impact To Patient	1	1
Injury	1	1
Foreign Body In Patient	1	1
No Known Impact Or Consequence To Patient	1	1
No Clinical Signs, Symptoms or Conditions	1	1