Lem Hemorrhoidal Ligator, Models A.5650, A.5660

Q: What is the product code of K070881?

The FDA product code is FHN – Ligator, Hemorrhoidal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.

FDA 510(k) K070881 · Sapimed S.P.A.

Substantially Equivalent

510(k) numberK070881

Submission

Device name: Lem Hemorrhoidal Ligator, Models A.5650, A.5660
Applicant: Sapimed S.P.A.
Crofton, MD, US
Received: March 30, 2007
Decision date: September 26, 2007
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FHN – Ligator, Hemorrhoidal
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.4400
Specialty: Gastroenterology, Urology

Other 510(k)s with product code FHN

510(k)	Device	Applicant	Decision
K213223	Multi-Band LigatorFHN · Traditional	Beijing Zksk Technology Co., Ltd.	06/06/2022SE
K172985	Ligation DeviceFHN · Traditional	Leo Medical Co., Ltd.	06/14/2018SE
K150718	Wi-3 HAL-RAR SystemFHN · Traditional	Agency For Medical Innovations GmbH	06/12/2015SE
K131282	Nexus Hemorrhoid LigatorFHN · Traditional	Inx Medical	07/11/2013SE
K093497	THD BandyFHN · Traditional	Thd Spa	07/15/2010SE
K091519	Haemoband Multi-LigatorFHN · Traditional	Haemoband Surgical, Ltd.	07/28/2009SE
K020824	Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238FHN · Special	Boston Scientific Corp	04/12/2002SE
K020526	Modification to Wilson-Cook Multiple Band LigatorFHN · Special	Don Wilson/Wilson-Cook Medical, Inc.	03/19/2002SE
K001236	Riza Band Stretcher (RBS)-60000FHN · Traditional	R-Med, Inc.	07/17/2000SE
K000297	Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod.…FHN · Traditional	Erchinger Medizintecnik	04/24/2000SE

More from Erchinger Medizintecnik

510(k)	Device	Decision
K070913	Self-Light Disposable AnoscopeFER · Traditional	08/10/2007SE
K070915	Sapimed Disposable SigmoidoscopeKDM · Traditional	07/06/2007SE

Questions and answers

When was Lem Hemorrhoidal Ligator, Models A.5650, A.5660 cleared by the FDA?

Lem Hemorrhoidal Ligator, Models A.5650, A.5660 (K070881) received a 510(k) decision of Substantially Equivalent on September 26, 2007, 180 days after the submission was received.

What is the product code of K070881?

The FDA product code is FHN – Ligator, Hemorrhoidal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.