Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 obstetrical kit
Regulation Description Obstetric-gynecologic general manual instrument.
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeOKV
Regulation Number 884.4520
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 1 1
2022 2 2
2023 1 1
2024 4 4
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 3 3
Entrapment of Device 2 2
Structural Problem 2 2
Break 1 1
Crack 1 1
Component Missing 1 1
Sharp Edges 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Aspiration/Inhalation 1 1
Laceration(s) 1 1
Nasal Obstruction 1 1
No Consequences Or Impact To Patient 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Nov-14-2024
2 Avid Medical, Inc. II Mar-19-2020
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
-
-