FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
K Number: K970619
·
Decision Nov 19, 1997
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
9
Review Days
274
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
- GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
- K Number
- K970619
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilson Greatbatch Technologies, Inc.
- Date Received
- February 18, 1997
- Decision Date
- November 19, 1997
- Product Code
- CCW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCW), ordered by most recent decision date.
APA Oxy Blade
FDA 510(k)
FDA Class 1
·Anesthesiology
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
FDA 510(k)
FDA Class 1
·Anesthesiology
YEESCOPE LARYNGOSCOPES
FDA 510(k)
FDA Class 1
·Anesthesiology
AIRTRAQ SP AIRTRAQ AVANT
FDA 510(k)
FDA Class 1
·Anesthesiology
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
FDA 510(k)
FDA Class 1
·Anesthesiology
TRU-MR LARYNGOSCOPE SET
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Wilson Greatbatch Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971374 | GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE | May 13, 1998 | Substantially Equivalent |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Apr 30, 1998 | Substantially Equivalent |
| K972280 | GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES | Dec 11, 1997 | Substantially Equivalent |
| K971781 | GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES | Nov 21, 1997 | Substantially Equivalent |
| K971375 | GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE | Oct 31, 1997 | Substantially Equivalent |
| K954649 | WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP | Dec 22, 1995 | Substantially Equivalent |
| K950063 | WGL ENDOSCOPIC GRASPER* | Jan 27, 1995 | Substantially Equivalent |
| K942168 | WGL ENDOSCOPIC GRASPER | Dec 13, 1994 | Substantially Equivalent |