FAM · Class II · 21 CFR 876.1500

FDA Product Code FAM: Sigmoidoscope And Accessories, Flexible/rigid

To Examine And Perform Procedures Within The Sigmoid (descending) Colon

Leading manufacturers include Pentax Precision Instrument Corp., Vision-Sciences, Inc. and Welch Allyn, Inc..

24
Total
24
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Sigmoidoscope And Accessories, Flexible/rigid Devices (Product Code FAM)

24 devices
1–24 of 24
Cleared Jun 27, 1997
ENDOSCOPE
K964131
Akos Biomedical, Inc.
Gastroenterology & Urology · 255d
Cleared Apr 17, 1997
VS-100 VIDEO SIGMOIDOSCOPE
K970382
Welch Allyn, Inc.
Gastroenterology & Urology · 73d
Cleared Jan 03, 1997
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
K964326
Vision-Sciences, Inc.
Gastroenterology & Urology · 65d
Cleared Dec 16, 1996
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
K964100
Vision-Sciences, Inc.
Gastroenterology & Urology · 66d
Cleared Nov 21, 1996
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
K963344
Vision-Sciences, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 24, 1996
ES-3840, VIDEO SIGMOIDOSCOPE
K961567
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 62d
Cleared Mar 21, 1996
ES-3800, VIDEO SIGMOIDOSCOPE
K951577
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 352d
Cleared Aug 01, 1995
VIDEO SIGMOIDOSCOPE
K950429
Welch Allyn, Inc.
Gastroenterology & Urology · 180d
Cleared Jun 29, 1995
FS-34P2, FIBER SIGMOIDOSCOPE
K951576
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 86d
Cleared Jun 27, 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FS-38H, FIBER SIGMOIDOSCOPE
K951573
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 84d
Cleared Feb 14, 1994
FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH
K932843
Vision-Sciences, Inc.
Gastroenterology & Urology · 248d
Cleared Oct 28, 1992
FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM
K921690
Vision-Sciences, Inc.
Gastroenterology & Urology · 203d
Cleared Apr 01, 1982
FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3
K820790
American Optical Corp.
Gastroenterology & Urology · 9d
Cleared Nov 02, 1981
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
K812965
American Optical Corp.
Gastroenterology & Urology · 11d
Cleared Dec 10, 1979
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 21d
Cleared Dec 06, 1979
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
K792314
Icl Scientific
Immunology · 20d
Cleared Apr 23, 1979
SIGMOIDOSCOPE TIPLESS
K790610
Welch Allyn, Inc.
Gastroenterology & Urology · 25d
Cleared Feb 18, 1977
SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125
K770291
Welch Allyn, Inc.
Gastroenterology & Urology · 4d
Cleared Jan 05, 1977
SIGMOIDOSCOPE/ DISPOSABLE
K761180
Smithkline Diagnostics, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 02, 1976
BRIDGE, SHORT DEFLECTING
K760173
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 149d

About Product Code FAM - Regulatory Context