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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, biopsy
Regulation Description Gastroenterology-urology biopsy instrument.
Product CodeKNW
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVITUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CANYON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
FORCYTE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEOTEK MEDIKAL LTD STI
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SHENGWEI MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
H.S HOSPITAL SERVICE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
INRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ITP INNOVATIVE TOMOGRAPHY PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
LAURANE MEDICAL SAS
  SUBSTANTIALLY EQUIVALENT 1
NEODYNAMICS AB
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
RANFAC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RESITU MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TEESUVAC APS
  SUBSTANTIALLY EQUIVALENT 1
TRIOPSY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
URAMIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
URO-1 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
URO-1, INC.
  SUBSTANTIALLY EQUIVALENT 2
XAGA SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 1020 1023
2022 535 540
2023 931 937
2024 1283 1286
2025 1695 1695
2026 1630 1632

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 3526 3528
Failure to Obtain Sample 930 930
Adverse Event Without Identified Device or Use Problem 393 394
Self-Activation or Keying 384 384
Difficult to Remove 346 346
Break 246 251
Material Twisted/Bent 242 244
Device Contamination with Chemical or Other Material 205 205
Tear, Rip or Hole in Device Packaging 176 176
Failure to Prime 144 144
Detachment of Device or Device Component 105 105
Device Markings/Labelling Problem 95 95
Material Fragmentation 78 78
Unintended Movement 77 77
Device-Device Incompatibility 67 67
Firing Problem 57 57
Device Difficult to Setup or Prepare 57 57
Packaging Problem 56 56
Suction Problem 56 56
Contamination 47 47
Mechanical Problem 46 46
Application Program Problem 37 37
Activation, Positioning or Separation Problem 34 34
Positioning Problem 33 33
Fluid/Blood Leak 31 31
Fracture 31 31
Improper or Incorrect Procedure or Method 29 29
Material Separation 28 28
Nonstandard Device 24 24
Patient Device Interaction Problem 23 23
Unsealed Device Packaging 23 23
Insufficient Device Problem Information 23 23
Material Deformation 21 21
Use of Device Problem 20 20
Illegible Information 20 20
Difficult to Insert 19 19
Product Quality Problem 18 18
Dull, Blunt 16 16
Misfire 16 17
Suction Failure 16 16
Failure to Cycle 15 15
Component Misassembled 14 14
Failure to Read Input Signal 14 14
Mechanical Jam 14 15
Filling Problem 14 14
Crack 14 14
Device Emits Odor 13 13
Accessory Incompatible 12 12
Missing Information 11 11
Premature Separation 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6221 6232
Insufficient Information 225 235
Hemorrhage/Blood Loss/Bleeding 169 170
Foreign Body In Patient 126 126
Hematoma 100 100
Pneumothorax 67 67
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 60 60
Pain 56 56
Needle Stick/Puncture 49 49
Laceration(s) 21 21
Breast Discomfort/Pain 20 20
Device Embedded In Tissue or Plaque 16 16
Hemoptysis 14 14
Discomfort 9 9
Syncope/Fainting 8 8
Perforation 8 8
Unspecified Tissue Injury 7 7
Unspecified Infection 7 7
Air Embolism 7 7
Swelling/ Edema 6 6
Necrosis 6 6
Perforation of Vessels 5 5
Chest Pain 5 5
Hematuria 5 5
Low Blood Pressure/ Hypotension 4 4
Partial thickness (Second Degree) Burn 4 4
Bacterial Infection 4 4
Fever 4 4
Pseudoaneurysm 4 4
No Consequences Or Impact To Patient 3 3
Intraoperative Pain 3 3
Kidney injury 3 3
Erythema 3 3
Inflammation 2 2
Hypersensitivity/Allergic reaction 2 2
Anxiety 2 2
Cardiac Arrest 2 2
Urinary Retention 2 2
Respiratory Insufficiency 2 2
Pericardial Effusion 2 2
Abscess 2 2
Extravasation 2 2
Skin Tears 2 2
Sepsis 2 2
Nerve Damage 2 2
Bruise/Contusion 2 2
Calcium Deposits/Calcification 2 2
Distress 2 2
Bowel Perforation 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc I Jul-10-2026
2 Argon Medical Devices, Inc II Sep-20-2024
3 Argon Medical Devices, Inc II Dec-09-2021
4 Arrow International Inc II Apr-07-2021
5 BIOPSYBELL S.R.L. II May-19-2021
6 Bard Peripheral Vascular Inc II Nov-15-2024
7 Bard Peripheral Vascular Inc II Jan-05-2024
8 Bard Peripheral Vascular Inc II Oct-04-2023
9 Bard Peripheral Vascular Inc II May-05-2023
10 Bard Peripheral Vascular Inc II Mar-16-2023
11 Bard Peripheral Vascular Inc II Oct-19-2021
12 Bard Peripheral Vascular Inc II Aug-12-2021
13 Bard Peripheral Vascular Inc II Mar-22-2021
14 Hologic, Inc II Feb-06-2026
15 Hologic, Inc II Feb-13-2025
16 Hologic, Inc II Jun-29-2023
17 M.D.L. S.r.l. II Sep-20-2021
18 Merit Medical Systems, Inc. II Oct-27-2022
19 Remington Medical, Inc. II Dec-28-2022
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