FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STYLET TRACHAEL TUBE
K Number: K905133
·
Decision Apr 22, 1991
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
49
Review Days
158
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
- STYLET TRACHAEL TUBE
- K Number
- K905133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5790
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Devices, Inc.
- Date Received
- November 15, 1990
- Decision Date
- April 22, 1991
- Product Code
- BSR
- 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 |
|---|---|---|---|
| BSR | Stylet, Tracheal Tube | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSR), ordered by most recent decision date.
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
FDA 510(k)
FDA Class 1
·Anesthesiology
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
FDA 510(k)
FDA Class 1
·Anesthesiology
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
FDA 510(k)
FDA Class 1
·Anesthesiology
MOLLOY INTUBATING STYLETTE
FDA 510(k)
FDA Class 1
·Anesthesiology
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
FDA 510(k)
FDA Class 1
·Anesthesiology
LIGHTED FLEXGUIDE (MODIFICATION)
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | Feb 5, 2001 | Substantially Equivalent |
| K930084 | MICRO-ARTHROSCOPE | Sep 1, 1995 | Substantially Equivalent for Some Indications |
| K943126 | ELECTROFLEX | Dec 5, 1994 | Substantially Equivalent |
| K940012 | SMARTBRACE ELECTRODE | Dec 5, 1994 | Substantially Equivalent |
| K935132 | HOME MICROCURRENT HMC | Mar 14, 1994 | Substantially Equivalent |
| K934619 | FLEXMATE | Feb 23, 1994 | Substantially Equivalent |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Jul 6, 1993 | Substantially Equivalent |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |