SPETZLER ROUND HANDLE APPLIERS - C-3753
510(k) K994191
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994191 | Date8 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HCI
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4175
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Spetzler Round Handle Appliers are surgical instruments classified as aneurysm clip appliers, designed specifically for use with titanium aneurysm clips during neurosurgical procedures. These devices are engineered to assist neurosurgeons in the precise application of clips to intracranial aneurysms, facilitating secure occlusion while minimising trauma to surrounding tissues.
These appliers are intended for single-use in sterile operating room environments and are regulated under FDA 510(k) clearance (K994191) as Class II devices under regulation 882.4175. Models C-3753, C-3753T, C-3754, and C-3754T are supplied sterile and are compatible with MRI-safe titanium aneurysm clips. Proper storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
Other devices from Nmt Medical, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these appliers reusable or intended for single-use in the operating room?
These Spetzler Round Handle Appliers (models C-3753, C-3753T, C-3754, and C-3754T) are explicitly designed for single-use only in sterile operating room environments. The manufacturer emphasizes this to ensure sterility and functionality during neurosurgical procedures, particularly when applying titanium aneurysm clips.
What types of aneurysm clips are these appliers compatible with, and do they work with MRI-safe materials?
The Spetzler Round Handle Appliers are engineered specifically for use with MRI-safe titanium aneurysm clips. This compatibility ensures they can be safely used in MRI environments without interference, which is critical for postoperative imaging of intracranial aneurysms.
How should I store these appliers to maintain their sterility and performance?
To preserve sterility and functionality, these appliers must be stored according to the manufacturer’s guidelines. Since they are supplied sterile and intended for single-use, proper packaging and handling (e.g., avoiding contamination or exposure to moisture) are essential before use in the operating room.
What distinguishes the different models (e.g., C-3753 vs. C-3754) of these appliers?
While the exact differences between the models (C-3753, C-3753T, C-3754, C-3754T) aren’t detailed in the specifications, the ‘T’ suffix (e.g., C-3753T) often denotes a titanium variant or a slight modification in design (e.g., enhanced grip or ergonomics). For precise distinctions, refer to the manufacturer’s documentation or contact Nmt Medical directly, as these variations may affect handling or clip compatibility.
What regulatory pathway was followed for FDA clearance of these aneurysm clip appliers?
These appliers were cleared through the FDA’s 510(k) process (traditional pathway, K994191) under Class II regulation 882.4175, with a substantially equivalent (SESE) determination by the Neurology (NE) Advisory Committee. The clearance confirms they meet FDA standards for aneurysm clip appliers in neurosurgery, though clinical use remains at the surgeon’s discretion.