Comeg Endoscopy Grasping Forceps

Q: What is the product code of K970489?

The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.

FDA 510(k) K970489 · Comeg Endoscopy

Substantially Equivalent

510(k) numberK970489

Submission

Device name: Comeg Endoscopy Grasping Forceps
Applicant: Comeg Endoscopy
Aurora, CO, US
Received: February 10, 1997
Decision date: March 19, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FFL – Dislodger, Stone, Basket, Ureteral, Metal
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.4680
Specialty: Gastroenterology, Urology

Other 510(k)s with product code FFL

510(k)	Device	Applicant	Decision
K190492	Peralta Stone Removal CatheterFFL · Traditional	Calcula Technologies, Inc.	07/18/2019SE
K172299	Accordion Piccolo Stone Management DeviceFFL · Special	Ths International, Inc. D/B/A Accordion Medical	09/19/2017SE
K102887	Accordion Stone Management Device Model AC281205 and AC3814510FFL · Traditional	Percutaneous Systems, Inc.	05/16/2011SE
K082803	Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015FFL · Traditional	Percutaneous Systems, Inc.	11/13/2008SE
K052048	AccordionFFL · Traditional	Percutaneous Systems, Incorporated	09/13/2005SE
K012581	Reprocessed Stone Retrieval BasketsFFL · Traditional	Sterilmed, Inc.	02/14/2002SE
K972091	Ams Foreign Body ExtratorFFL · Traditional	American Medical Systems, Inc.	08/29/1997SE
K962387	Olympus FG-45/46-1 Grasping Forceps(Urology)FFL · Traditional	Olympus America, Inc.	07/31/1996SE
K961248	Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone…FFL · Traditional	C.R. Bard, Inc.	05/28/1996SE
K955049	Olympus FG-45/46-1 Grasping ForcepsFFL · Traditional	Olympus America, Inc.	12/15/1995SE

More from Olympus America, Inc.

510(k)	Device	Decision
K971881	Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarr…FJL · Traditional	08/12/1997SE
K970764	Comeg Endoscopy Resectoscope AccessoriesOCX · Traditional	04/22/1997SE

Questions and answers

When was Comeg Endoscopy Grasping Forceps cleared by the FDA?

Comeg Endoscopy Grasping Forceps (K970489) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 37 days after the submission was received.

What is the product code of K970489?

The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.