FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
K Number: K812965
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
35
Review Days
11
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Basic Information
- Device Name
- MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
- K Number
- K812965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Optical Corp.
- Date Received
- October 22, 1981
- Decision Date
- November 2, 1981
- 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.
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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
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ES-3840, VIDEO SIGMOIDOSCOPE
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Other Clearances by American Optical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K950881 | PHACO TIP | Sep 6, 1995 | Substantially Equivalent |
| K950880 | AOI UNIVERSAL ULTRASONIC HANDPIECE | May 26, 1995 | Substantially Equivalent |
| K931358 | AORP4000 REUSABLE PAK | Feb 22, 1994 | Substantially Equivalent |
| K931354 | P4000 PHACOEMULSIFIER | Feb 22, 1994 | Substantially Equivalent |
| K931357 | AOD4000 DISPOSABLE PAK | Jan 25, 1994 | Substantially Equivalent |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | Apr 1, 1982 | Substantially Equivalent |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | Dec 29, 1981 | Substantially Equivalent |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | Sep 8, 1981 | Substantially Equivalent |
| K812063 | SR-1V DATA PRINTER | Aug 18, 1981 | Substantially Equivalent |
| K811535 | MODEL FUS-1, FLEXIBLE URETEROSCOPE | Jun 23, 1981 | Substantially Equivalent |