Tray, Surgical, Needle

Device Code: 5510

Product Code(s): FSH

Device Classification Information

• Device Type ID: 5510
• Device Name: Tray, Surgical, Needle
• 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 Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 878.4800 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FSH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5510
• Device: Tray, Surgical, Needle
• Product Code: FSH
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Surgical Instrument For General Use.
• CFR Regulation Number: 878.4800 [🔎]

Device Problems
Structural Problem	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Carefusion 2200 Inc	II	Apr-18-2018

TPLC Last Update: 2019-04-02 21:07:31