# K994191: Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T

- Pathway: 510(k) (Traditional)
- Applicant: Nmt Medical, Inc.
- Decided: Feb 8, 2000 after 57 days
- Product code: HCI (Applier, Aneurysm Clip)
- Device class: 2
- Regulation: 21 CFR 882.4175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K772200 (1977). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955064: Spetzler TI 100 Aneurysm Clip, Elekta Instruments, Inc. (1996) Summary page 3.
- K984109: Aesculap Axial Clip Applier, Aesculap, Inc. (1999) Summary page 3.
- K940970: Yasargil, Caspar, Vario Clip Appliers, Aesculap, Inc. (1995) Summary page 3.
- K982379: Sundt Slim-Line Aneurysm Clip Applier, Johnson & Johnson Professionals, Inc. (1998) Summary page 3.

## Indications for use
Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm. The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.

Source page: https://510kreport.com/device/K994191
Methodology: https://510kreport.com/methodology