Needle, Neurosurgical Suture

Device Code: 3698

Product Code(s): HAS

Device Classification Information

• Device Type ID: 3698
• Device Name: Needle, Neurosurgical Suture
• Regulation Description: Neurosurgical Suture Needle.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 882.4650 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: HAS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-270 ASTM F1840-10 (Reapproved 2016)
  Standard Terminology For Surgical Suture Needles
• 6-271 ASTM F1874-98
  Standard Test Method For Bend Testing Of Needles Used In Surgical Sutures
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice For Permanent Marking Of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice For Care And Handling Of Orthopedic Implants And Instruments

Total Product Life Cycle

• Device Type ID: 3698
• Device: Needle, Neurosurgical Suture
• Product Code: HAS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Neurosurgical Suture Needle.
• CFR Regulation Number: 882.4650 [🔎]

TPLC Last Update: 2019-04-02 20:34:42