FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RUSCH ENDOTRACHEAL TUBE STYLET
K Number: K952100
·
Decision Aug 8, 1995
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
26
Review Days
96
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
- RUSCH ENDOTRACHEAL TUBE STYLET
- K Number
- K952100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5790
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rusch, Inc.
- Date Received
- May 4, 1995
- Decision Date
- August 8, 1995
- 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 Rusch, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010420 | RUSCH MMG/O'NEIL CATHETER | May 9, 2001 | Substantially Equivalent |
| K993528 | RUSCH EMERGENCY MASK | May 31, 2000 | Substantially Equivalent |
| K993194 | RUSCH MANUAL RESUSCITATOR BAG | Mar 24, 2000 | Substantially Equivalent |
| K980870 | RUSCH SILICONE FOLEY CATHETER | Jun 9, 1998 | Substantially Equivalent |
| K974419 | RUSCH SIMPLASTIC COUNCILL TIP CATHETER | Jan 27, 1998 | Substantially Equivalent |
| K963779 | RUSCH ENTERAL FEEDING TUBE | May 23, 1997 | Substantially Equivalent |
| K970021 | RUSCH SUPRAPUBIC TRAY | Feb 7, 1997 | Substantially Equivalent |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Dec 17, 1996 | Substantially Equivalent |
| K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | Jun 28, 1996 | Substantially Equivalent |
| K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | Jun 27, 1996 | Substantially Equivalent |