FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
K Number: K023259
·
Decision Dec 26, 2002
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
111
Applicant Total
14
Review Days
87
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Basic Information
- Device Name
- INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
- K Number
- K023259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helix Medical, Inc.
- Date Received
- September 30, 2002
- Decision Date
- December 26, 2002
- Product Code
- FDF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Helix Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | Aug 1, 1990 | Substantially Equivalent |