Surgical Instruments, G-u, Manual (and Accessories)

Device Code: 1964

Product Code(s): KOA

Device Classification Information

• Device Type ID: 1964
• Device Name: Surgical Instruments, G-u, Manual (and Accessories)
• Regulation Description: Manual Gastroenterology-urology Surgical Instrument And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 876.4730 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KOA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-272 ASTM F2062-00 (Reapproved 2011)
  Standard Specification For Square Drive Interconnections On Surgical Instruments

Total Product Life Cycle

• Device Type ID: 1964
• Device: Surgical Instruments, G-u, Manual (and Accessories)
• Product Code: KOA
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Gastroenterology-urology Surgical Instrument And Accessories.
• CFR Regulation Number: 876.4730 [🔎]

Premarket Reviews
Manufacturer	Decision
AGENCY FOR MEDICAL INNOVATIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Material Fragmentation	1
Difficult To Insert	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Jun-08-2017

TPLC Last Update: 2019-04-02 20:02:54