FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
K Number: K915804
·
Decision Mar 20, 1992
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
25
Review Days
87
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
- PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
- K Number
- K915804
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Propper Mfg. Co., Inc.
- Date Received
- December 24, 1991
- Decision Date
- March 20, 1992
- 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 Propper Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | Apr 5, 2012 | Substantially Equivalent |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | May 25, 2011 | Substantially Equivalent |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | Jul 8, 2009 | Substantially Equivalent |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | Aug 17, 2004 | Substantially Equivalent |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | Jan 24, 2001 | Substantially Equivalent |
| K991276 | PASS/FAIL CHALLENGE PACK | Jul 12, 1999 | Substantially Equivalent |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | Nov 6, 1998 | Substantially Equivalent |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | Jan 9, 1998 | Substantially Equivalent |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | Apr 1, 1997 | Substantially Equivalent |
| K921798 | PROPPER SUPER SERACULT(R) | Oct 5, 1992 | Substantially Equivalent |