Panels › Gastroenterology, Urology › Product code FAM · Class 2
Sigmoidoscope And Accessories, Flexible/Rigid
Regulation 876.1500
0510(k)s in 12 months (24 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FAM
| Company | 510(k)s | Recalls |
|---|---|---|
| Pentax Precision Instrument Corp. | 6 | 0 |
| Vision-Sciences, Inc. | 5 | 0 |
| Welch Allyn, Inc. | 4 | 0 |
| American Optical Corp. | 2 | 0 |
| Pentax Medical Company | 0 | 2 |
| Akos Biomedical, Inc. | 1 | 0 |
| Dynatech Cryomedical Co. | 1 | 0 |
| Harvard Laboratories | 1 | 0 |
| Icl Scientific | 1 | 0 |
| Schott Fiber Optics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 1997 | K964131 | ENDOSCOPE Akos Biomedical, Inc. | FAM |
| Apr 17, 1997 | K970382 | VS-100 VIDEO SIGMOIDOSCOPE Welch Allyn, Inc. | FAM |
| Jan 3, 1997 | K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM Vision-Sciences, Inc. | FAM |
| Dec 16, 1996 | K964100 | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 Vision-Sciences, Inc. | FAM |
| Nov 21, 1996 | K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE Vision-Sciences, Inc. | FAM |
| Jun 24, 1996 | K961567 | ES-3840, VIDEO SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Mar 21, 1996 | K951577 | ES-3800, VIDEO SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Aug 1, 1995 | K950429 | VIDEO SIGMOIDOSCOPE Welch Allyn, Inc. | FAM |
| Jun 29, 1995 | K951576 | FS-34P2, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Jun 27, 1995 | K951573 | FS-38H, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Jun 27, 1995 | K951572 | FS-38X, FIBER SIGMOIDOSCOPE Pentax Precision Instrument Corp. | FAM |
| Feb 14, 1994 | K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH Vision-Sciences, Inc. | FAM |
| Oct 28, 1992 | K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM Vision-Sciences, Inc. | FAM |
| Apr 25, 1989 | K892000 | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE Schott Fiber Optics, Inc. | FAM |
| Nov 17, 1982 | K822765 | SIGMOIDOSCOPE, FLEXIBLE Harvard Laboratories | FAM |
| Apr 1, 1982 | K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 American Optical Corp. | FAM |
| Nov 2, 1981 | K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE American Optical Corp. | FAM |
| Dec 10, 1979 | K792341 | PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 Pentax Precision Instrument Corp. | FAM |
| Dec 6, 1979 | K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN Icl Scientific | FAM |
| Apr 23, 1979 | K790610 | SIGMOIDOSCOPE TIPLESS Welch Allyn, Inc. | FAM |
| Oct 7, 1977 | K771815 | SIGMOSCOPE Dynatech Cryomedical Co. | FAM |
| Feb 18, 1977 | K770291 | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 Welch Allyn, Inc. | FAM |
| Jan 5, 1977 | K761180 | SIGMOIDOSCOPE/ DISPOSABLE Smithkline Diagnostics, Inc. | FAM |
| Dec 2, 1976 | K760173 | BRIDGE, SHORT DEFLECTING V. Mueller O.V. Baxter Healthcare Corp. | FAM |
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