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., Welch Allyn, Inc. and American Optical Corp..

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 Apr 17, 1997
VS-100 VIDEO SIGMOIDOSCOPE
K970382
Welch Allyn, Inc.
Gastroenterology & Urology · 73d
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 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