Punch, Surgical

Device Code: 5729

Product Code(s): LRY

Device Type ID	5729
Device Name	Punch, Surgical
Regulation Description	Manual Surgical Instrument For General Use.
Regulation Medical Specialty	General & Plastic Surgery
Review Panel	General & Plastic Surgery
Premarket Review	Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type	510(K) Exempt
CFR Regulation Number	878.4800 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	LRY
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	5729
Device	Punch, Surgical
Product Code	LRY
FDA Device Classification	Class 1 Medical Device
Regulation Description	Manual Surgical Instrument For General Use.
CFR Regulation Number	878.4800 [🔎]

Device Problems
Break	144
Material Deformation	35
Appropriate Term/Code Not Available	31
Naturally Worn	17
Loose Or Intermittent Connection	10
Crack	8
Material Fragmentation	6
Bent	6
Material Twisted / Bent	6
Fracture	4
Device-Device Incompatibility	4
Dull, Blunt	4
Fitting Problem	3
Device Operates Differently Than Expected	3
Connection Problem	3
Device Dislodged Or Dislocated	2
Disassembly	2
Material Integrity Problem	2
Device Contamination With Chemical Or Other Material	2
Physical Resistance / Sticking	2
Device Issue	2
Detachment Of Device Component	1
Positioning Problem	1
Device Damaged Prior To Use	1
Thermal Decomposition Of Device	1
Difficult To Insert	1
Device Or Device Fragments Location Unknown	1
Detachment Of Device Or Device Component	1
Insufficient Information	1
Failure To Adhere Or Bond	1
Contamination During Use	1
Difficult To Remove	1
Incorrect Measurement	1
Component Missing	1
Activation, Positioning Or Separation Problem	1
Delivered As Unsterile Product	1
Contamination / Decontamination Problem	1
Total Device Problems	312

TPLC Last Update: 2019-04-02 21:11:33