FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED ENT SHAVERS
K Number: K081814
·
Decision Dec 17, 2008
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
64
Review Days
174
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
- REPROCESSED ENT SHAVERS
- K Number
- K081814
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterilmed, Inc.
- Date Received
- June 26, 2008
- Decision Date
- December 17, 2008
- 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 Sterilmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Oct 11, 2024 | Substantially Equivalent |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | Nov 14, 2019 | Substantially Equivalent |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Aug 15, 2019 | Substantially Equivalent |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Apr 15, 2019 | Substantially Equivalent |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | Nov 21, 2016 | Substantially Equivalent |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | Sep 20, 2016 | Substantially Equivalent |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | Jun 23, 2016 | Substantially Equivalent |
| K152090 | Reprocessed Steerable Introducer | Mar 23, 2016 | Substantially Equivalent |
| K152134 | Reprocessed Vessel Sealer | Jan 15, 2016 | Substantially Equivalent |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Aug 27, 2015 | Substantially Equivalent |