FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGMOIDOSCOPE/ DISPOSABLE
K Number: K761180
·
Decision Jan 5, 1977
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
42
Review Days
34
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Basic Information
- Device Name
- SIGMOIDOSCOPE/ DISPOSABLE
- K Number
- K761180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- December 2, 1976
- Decision Date
- January 5, 1977
- Product Code
- FAM
- 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 |
|---|---|---|---|
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAM), ordered by most recent decision date.
ENDOSCOPE
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VS-100 VIDEO SIGMOIDOSCOPE
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VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
FDA 510(k)
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VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ES-3840, VIDEO SIGMOIDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Smithkline Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961062 | FLEXSURE OBT | Nov 6, 1996 | Substantially Equivalent |
| K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | Jun 7, 1996 | Substantially Equivalent |
| K934863 | FLEXSURE HP | May 18, 1994 | Substantially Equivalent |
| K880499 | HEMOCCULT SENSITIVE TEST | May 23, 1988 | Substantially Equivalent |
| K875131 | (SKD) CHOLESTEROL TEST KIT | Mar 1, 1988 | Substantially Equivalent |
| K862849 | HEMOCCULT WIPE TEST | Dec 9, 1986 | Substantially Equivalent |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 5, 1986 | Substantially Equivalent |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | Jul 24, 1985 | Substantially Equivalent |
| K821884 | GASTROCCULT TM | Oct 8, 1982 | Substantially Equivalent |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Jun 22, 1982 | Substantially Equivalent |