Stryker ESSX Microdebrider System
by Stryker Ireland Ltd., Instruments Division
510(k) K073633
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073633 | Date26 Aug 2008 | 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- Withdrawn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
- ERL
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4250
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Stryker ESSX Microdebrider System is a surgical drill designed for use in ear, nose, and throat procedures. Classified as a Class II electric or pneumatic surgical drill for ENT applications, it is specifically engineered to remove tissue and shape bone during intranasal and sinus surgeries with precision and controlled access.
This system is intended for use in operating room settings and is supplied as a reusable medical device. It is not MRI-safe and requires appropriate storage and handling to maintain sterility. The device holds an FDA 510(k) clearance under regulation number 21 CFR 874.4250, with the advisory committee classification for Ear, Nose, and Throat procedures. Multiple model and registration numbers are associated with its regulatory submission.
Other devices from Stryker Ireland Ltd., Instruments Division
Questions
AI-generated answers, 20 Sep 2026
What types of procedures is the Stryker ESSX Microdebrider System designed for in the operating room?
The Stryker ESSX Microdebrider System is specifically engineered for intranasal and sinus surgeries, particularly within ear, nose, and throat (ENT) procedures. Its precision and controlled access make it ideal for removing tissue and shaping bone in these delicate anatomical areas.
Is the Stryker ESSX Microdebrider System reusable or single-use, and how should it be handled to maintain sterility?
The Stryker ESSX Microdebrider System is a reusable medical device, meaning it is intended for repeated use after proper cleaning, sterilization, and maintenance. Since it is not sterile out-of-the-box, it must be sterilized before each use and stored in a way that preserves its sterility—typically in a clean, dry environment as specified by the manufacturer’s instructions.
Can the Stryker ESSX Microdebrider System be used in an MRI environment, and what regulatory pathway does it follow?
No, the Stryker ESSX Microdebrider System is not MRI-safe, meaning it should not be used in an MRI environment due to potential interference or safety risks. Regulatory-wise, it holds an FDA 510(k) clearance under 21 CFR 874.4250, classified as a Class II electric or pneumatic surgical drill for ENT applications, with a substantially equivalent (SE) determination by the Ear, Nose, and Throat (EN) advisory committee.
Are there multiple models or variations of the Stryker ESSX Microdebrider System, and how are they differentiated?
Yes, the Stryker ESSX Microdebrider System includes multiple model and registration numbers (e.g., 3003678543, 2649614, etc.), as listed in the FDA’s OpenFDA database. While the core functionality remains consistent—precision tissue removal and bone shaping in ENT surgeries—these variations may correspond to specific accessories, attachments, or minor design iterations rather than fundamental changes in purpose. Always refer to the manufacturer’s documentation for exact model-specific details.