Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T

Q: What is the product code of K994191?

The FDA product code is HCI – Applier, Aneurysm Clip, a Class II (moderate risk) device regulated under 21 CFR 882.4175.

FDA 510(k) K994191 · Nmt Medical, Inc.

Substantially Equivalent

510(k) numberK994191

Submission

Device name: Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T
Applicant: Nmt Medical, Inc.
Marietta, GA, US
Received: December 13, 1999
Decision date: February 8, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HCI – Applier, Aneurysm Clip
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4175
Specialty: Neurology

Other 510(k)s with product code HCI

510(k)	Device	Applicant	Decision
K221524	Sugita AVM Microclip ApplierHCI · Special	Mizuho America, Inc.	06/24/2022SE
K211572	Aesculap Slim Clip ApplierHCI · Traditional	Aesculap, Inc.	12/13/2021SE
K180914	Aesculap Slim Clip ApplierHCI · Traditional	Aesculap, Inc.	04/17/2018SE
K173271	Aesculap Slim Clip Applier ForcepsHCI · Special	Aesculap, Inc.	11/10/2017SE
K010910	Medicon Yasargil Clip Applying ForcepsHCI · Traditional	Medicon EG	08/01/2001SE
K984109	Aesculap Axial Clip ApplierHCI · Traditional	Aesculap, Inc.	02/12/1999SE
K982379	Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional	Johnson & Johnson Professionals, Inc.	12/18/1998SE
K954658	Perneczky Clip Applier/RemoverHCI · Traditional	Von Zeppelin GmbH	10/08/1996SE
K940970	Yasargil, Caspar, Vario Clip AppliersHCI · Traditional	Aesculap, Inc.	01/24/1995SE
K902544	Sundt Avm Micro ClipHCI · Traditional	Codman & Shurtleff, Inc.	09/20/1990SE

More from Codman & Shurtleff, Inc.

510(k)	Device	Decision
K034025	NMT Medical Transseptal Sheath Set, Models TSS-10-HSC, TSS-11-HSC, TSS12-HSCDYB · Traditional	03/26/2004SE

Questions and answers

When was Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T cleared by the FDA?

Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T (K994191) received a 510(k) decision of Substantially Equivalent on February 8, 2000, 57 days after the submission was received.

What is the product code of K994191?

The FDA product code is HCI – Applier, Aneurysm Clip, a Class II (moderate risk) device regulated under 21 CFR 882.4175.