FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITEK ENDOTRACHEAL TUBE, LASER RESIS
K Number: K823757
·
Decision Apr 28, 1983
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
28
Review Days
135
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
- SURGITEK ENDOTRACHEAL TUBE, LASER RESIS
- K Number
- K823757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Engineering Corp.
- Date Received
- December 14, 1982
- Decision Date
- April 28, 1983
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTR), ordered by most recent decision date.
Spiro-VISTA
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
FDA 510(k)
FDA Class 2
·Anesthesiology
AeroJet Ventilation Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
FDA 510(k)
FDA Class 2
·Anesthesiology
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | Nov 18, 1993 | Substantially Equivalent |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Mar 13, 1991 | Substantially Equivalent |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | Jan 14, 1991 | Substantially Equivalent |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | Jul 16, 1990 | Substantially Equivalent |
| K884746 | SURGITEK FLAT T-SPAN | Aug 10, 1989 | Substantially Equivalent |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Feb 8, 1989 | Substantially Equivalent |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Aug 11, 1988 | Substantially Equivalent |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | May 26, 1988 | Substantially Equivalent |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | May 26, 1988 | Substantially Equivalent |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Sep 26, 1984 | Substantially Equivalent |