FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
K Number: K897005
·
Decision Mar 16, 1990
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
14
Review Days
88
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Basic Information
- Device Name
- BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
- K Number
- K897005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Helix Medical, Inc.
- Date Received
- December 18, 1989
- Decision Date
- March 16, 1990
- Product Code
- JOH
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
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Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
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Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
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Other Clearances by Helix Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | Dec 26, 2002 | Substantially Equivalent |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Jun 25, 1999 | Substantially Equivalent |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | Dec 9, 1994 | Substantially Equivalent |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Dec 2, 1994 | Substantially Equivalent |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | Apr 15, 1994 | Substantially Equivalent |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | Dec 15, 1993 | Substantially Equivalent |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | May 17, 1993 | Substantially Equivalent |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | Sep 10, 1992 | Substantially Equivalent |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | Jun 30, 1992 | Substantially Equivalent |
| K904729 | BLOM-SINGER SHOWER GUARD | Feb 28, 1991 | Substantially Equivalent |