FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XPS STRAIGHTSHOT MICRORESECTOR
K Number: K972453
·
Decision Sep 5, 1997
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
82
Review Days
67
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
- XPS STRAIGHTSHOT MICRORESECTOR
- K Number
- K972453
- 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
- Xomed, Inc.
- Date Received
- June 30, 1997
- Decision Date
- September 5, 1997
- 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 Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Dec 11, 2000 | Substantially Equivalent |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Dec 4, 2000 | Substantially Equivalent |
| K002828 | XPS NITRO SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Oct 11, 2000 | Substantially Equivalent |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Jun 9, 2000 | Substantially Equivalent |
| K001148 | MEROGEL OTOLOGIC PACK | Jun 3, 2000 | Substantially Equivalent |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |