Sigmoidoscope And Accessories, Flexible/Rigid
The Sigmoidoscope and Accessories (Flexible/Rigid) (product code FAM) is an endoscopic device used to examine and perform procedures within the sigmoid (descending) colon, typically for diagnostic purposes or polypectomy. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.
Basic Information
- Product Code
- FAM
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
to examine and perform procedures within the sigmoid (descending) colon
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964131 | ENDOSCOPE | Jun 27, 1997 | Substantially Equivalent | AKOS BIOMEDICAL, INC. |
| K970382 | VS-100 VIDEO SIGMOIDOSCOPE | Apr 17, 1997 | Substantially Equivalent | WELCH ALLYN, INC. |
| K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM | Jan 03, 1997 | Substantially Equivalent | VISION-SCIENCES, INC. |
| K964100 | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 | Dec 16, 1996 | Substantially Equivalent | VISION-SCIENCES, INC. |
| K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE | Nov 21, 1996 | Substantially Equivalent | VISION-SCIENCES, INC. |
| K961567 | ES-3840, VIDEO SIGMOIDOSCOPE | Jun 24, 1996 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K951577 | ES-3800, VIDEO SIGMOIDOSCOPE | Mar 21, 1996 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K950429 | VIDEO SIGMOIDOSCOPE | Aug 01, 1995 | Substantially Equivalent | WELCH ALLYN, INC. |
| K951576 | FS-34P2, FIBER SIGMOIDOSCOPE | Jun 29, 1995 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K951573 | FS-38H, FIBER SIGMOIDOSCOPE | Jun 27, 1995 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K951572 | FS-38X, FIBER SIGMOIDOSCOPE | Jun 27, 1995 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH | Feb 14, 1994 | Substantially Equivalent | VISION-SCIENCES, INC. |
| K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | Oct 28, 1992 | Substantially Equivalent | VISION-SCIENCES, INC. |
| K892000 | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE | Apr 25, 1989 | Substantially Equivalent | SCHOTT FIBER OPTICS, INC. |
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | Nov 17, 1982 | Substantially Equivalent | HARVARD LABORATORIES |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | Apr 01, 1982 | Substantially Equivalent | AMERICAN OPTICAL CORP. |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | Nov 02, 1981 | Substantially Equivalent | AMERICAN OPTICAL CORP. |
| K792341 | PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 | Dec 10, 1979 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN | Dec 06, 1979 | Substantially Equivalent | ICL SCIENTIFIC |
| K790610 | SIGMOIDOSCOPE TIPLESS | Apr 23, 1979 | Substantially Equivalent | WELCH ALLYN, INC. |
| K771815 | SIGMOSCOPE | Oct 07, 1977 | Substantially Equivalent | DYNATECH CRYOMEDICAL CO. |
| K770291 | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 | Feb 18, 1977 | Substantially Equivalent | WELCH ALLYN, INC. |
| K761180 | SIGMOIDOSCOPE/ DISPOSABLE | Jan 05, 1977 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K760173 | BRIDGE, SHORT DEFLECTING | Dec 02, 1976 | Substantially Equivalent | V. MUELLER O.V. BAXTER HEALTHCARE CORP. |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.