Atlas FDA

FAM

24 FDA 510(k) clearances · Product code

66 daysmedian time to decision
248 days90th percentile
24clearances measured

FDA profile

Official device name
Sigmoidoscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
to examine and perform procedures within the sigmoid (descending) colon
Adverse events (MAUDE)
1998: 2 · 2000: 4 · 2001: 2 · 2003: 1 · 2004: 3 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ENDOSCOPE (K964131)Akos Biomedical, Inc.1997-06-27
VS-100 VIDEO SIGMOIDOSCOPE (K970382)Welch Allyn, Inc.1997-04-17
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM (K964326)Vision-Sciences, Inc.1997-01-03
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.1996-12-16
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE (K963344)Vision-Sciences, Inc.1996-11-21
ES-3840, VIDEO SIGMOIDOSCOPE (K961567)Pentax Precision Instrument Corp.1996-06-24
ES-3800, VIDEO SIGMOIDOSCOPE (K951577)Pentax Precision Instrument Corp.1996-03-21
VIDEO SIGMOIDOSCOPE (K950429)Welch Allyn, Inc.1995-08-01
FS-34P2, FIBER SIGMOIDOSCOPE (K951576)Pentax Precision Instrument Corp.1995-06-29
FS-38H, FIBER SIGMOIDOSCOPE (K951573)Pentax Precision Instrument Corp.1995-06-27
FS-38X, FIBER SIGMOIDOSCOPE (K951572)Pentax Precision Instrument Corp.1995-06-27
FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH (K932843)Vision-Sciences, Inc.1994-02-14
FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM (K921690)Vision-Sciences, Inc.1992-10-28
FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE (K892000)Schott Fiber Optics, Inc.1989-04-25
SIGMOIDOSCOPE, FLEXIBLE (K822765)Harvard Laboratories1982-11-17
FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 (K820790)American Optical Corp.1982-04-01
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE (K812965)American Optical Corp.1981-11-02
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 (K792341)Pentax Precision Instrument Corp.1979-12-10
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN (K792314)Icl Scientific1979-12-06
SIGMOIDOSCOPE TIPLESS (K790610)Welch Allyn, Inc.1979-04-23
SIGMOSCOPE (K771815)Dynatech Cryomedical Co.1977-10-07
SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 (K770291)Welch Allyn, Inc.1977-02-18
SIGMOIDOSCOPE/ DISPOSABLE (K761180)Smithkline Diagnostics, Inc.1977-01-05
BRIDGE, SHORT DEFLECTING (K760173)V. Mueller O.V. Baxter Healthcare Corp.1976-12-02

Track FAM automatically

Every clearance here is in the API, with alerts when new ones post.