• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device laparoscope, general & plastic surgery, reprocessed
Definition The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLM
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2021 5 5
2022 5 5
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Problem with Sterilization 4 4
Detachment of Device or Device Component 4 4
Gas/Air Leak 2 2
Fracture 2 2
Nonstandard Device 1 1
Material Separation 1 1
Material Integrity Problem 1 1
Use of Device Problem 1 1
Failure to Cut 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
Foreign Body In Patient 2 2
Nausea 1 1
Pain 1 1
Vomiting 1 1
No Information 1 1

-
-