FAM — Sigmoidoscope And Accessories, Flexible/Rigid Class II
FDA product code FAM covers "Sigmoidoscope And Accessories, Flexible/Rigid", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FAM
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
to examine and perform procedures within the sigmoid (descending) colon
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K964131 | akos biomedical | ENDOSCOPE | June 27, 1997 |
| K970382 | welch allyn | VS-100 VIDEO SIGMOIDOSCOPE | April 17, 1997 |
| K964326 | vision-sciences | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH | January 3, 1997 |
| K964100 | vision-sciences | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FI | December 16, 1996 |
| K963344 | vision-sciences | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOID | November 21, 1996 |
| K961567 | pentax precision instrument | ES-3840, VIDEO SIGMOIDOSCOPE | June 24, 1996 |
| K951577 | pentax precision instrument | ES-3800, VIDEO SIGMOIDOSCOPE | March 21, 1996 |
| K950429 | welch allyn | VIDEO SIGMOIDOSCOPE | August 1, 1995 |
| K951576 | pentax precision instrument | FS-34P2, FIBER SIGMOIDOSCOPE | June 29, 1995 |
| K951573 | pentax precision instrument | FS-38H, FIBER SIGMOIDOSCOPE | June 27, 1995 |
| K951572 | pentax precision instrument | FS-38X, FIBER SIGMOIDOSCOPE | June 27, 1995 |
| K932843 | vision-sciences | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH | February 14, 1994 |
| K921690 | vision-sciences | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | October 28, 1992 |
| K892000 | schott fiber optics | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE | April 25, 1989 |
| K822765 | harvard laboratories | SIGMOIDOSCOPE, FLEXIBLE | November 17, 1982 |
| K820790 | american optical | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | April 1, 1982 |
| K812965 | american optical | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | November 2, 1981 |
| K792341 | pentax precision instrument | PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 | December 10, 1979 |
| K792314 | icl scientific | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN | December 6, 1979 |
| K790610 | welch allyn | SIGMOIDOSCOPE TIPLESS | April 23, 1979 |