FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER S2 DRILL
K Number: K141935
·
Decision Sep 26, 2014
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
81
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRYKER S2 DRILL
- K Number
- K141935
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- July 17, 2014
- Decision Date
- September 26, 2014
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERL), ordered by most recent decision date.
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
hekaDrill
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ORiGO System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AMADEO, M-UK1015 (incl. attachments and accessories)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Celeris, Disposable Sinus Debrider
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Stryker Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Aug 18, 2023 | Substantially Equivalent |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Feb 16, 2023 | Substantially Equivalent |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Feb 16, 2023 | Substantially Equivalent |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Oct 19, 2022 | Substantially Equivalent |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Sep 16, 2022 | Substantially Equivalent |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Jul 12, 2022 | Substantially Equivalent |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Feb 3, 2022 | Substantially Equivalent |
| K212055 | Connected OR Hub with Device and Voice Control | Dec 16, 2021 | Substantially Equivalent |
| K210377 | Stryker iBur hubs and cutting accessories | Jun 30, 2021 | Substantially Equivalent |
| K202964 | iBed Wireless with iBed Mobile | Jun 18, 2021 | Substantially Equivalent |