Needle, Suturing, Reusable

Device Code: 5631

Product Code(s): GDL

Device Classification Information

Device Type ID	5631
Device Name	Needle, Suturing, Reusable
Regulation Description	Manual Surgical Instrument For General Use.
Regulation Medical Specialty	General & Plastic Surgery
Review Panel	General & Plastic Surgery
Premarket Review	Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type	510(K) Exempt
CFR Regulation Number	878.4800 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	GDL
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

Total Product Life Cycle

Device Type ID	5631
Device	Needle, Suturing, Reusable
Product Code	GDL
FDA Device Classification	Class 1 Medical Device
Regulation Description	Manual Surgical Instrument For General Use.
CFR Regulation Number	878.4800 [🔎]

TPLC Last Update: 2019-04-02 21:09:48