SOD PUNCH SCOOP STRT 1.0MM
N/A - 3134076
Device Description
A surgical instrument designed to apply pressure to and/or cut the crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee (meniscus). At the proximal end is a handle, sometimes T-shaped (Smillie design), that tapers to a cutting blade at the distal end. The blade is available in various designs (e.g., straight, curved, single- or double-edged) and may enable a chisel-like cutting action. The device is typically made of high-grade stainless steel. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: HRX
Device Name: Arthroscope
Device Class: 2
Physical State: N/A
Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 888.1100
Third Party Flag: Y
Medical Specialty: OR
Device IdentifiersDevice Id: 00885556600122
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A