Product code FAM
- Device name
- Sigmoidoscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- to examine and perform procedures within the sigmoid (descending) colon
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964131 | ENDOSCOPE | Akos Biomedical, Inc. | 1997-06-27 |
| K970382 | VS-100 VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | 1997-04-17 |
| K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 1997-01-03 |
| 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. | 1996-12-16 |
| K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE | Vision-Sciences, Inc. | 1996-11-21 |
| K961567 | ES-3840, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-06-24 |
| K951577 | ES-3800, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 |
| K950429 | VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | 1995-08-01 |
| K951576 | FS-34P2, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-29 |
| K951573 | FS-38H, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 |
| K951572 | FS-38X, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 |
| K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH | Vision-Sciences, Inc. | 1994-02-14 |
| K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | Vision-Sciences, Inc. | 1992-10-28 |
| K892000 | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE | Schott Fiber Optics, Inc. | 1989-04-25 |
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | Harvard Laboratories | 1982-11-17 |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | American Optical Corp. | 1982-04-01 |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | American Optical Corp. | 1981-11-02 |
| K792341 | PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 | Pentax Precision Instrument Corp. | 1979-12-10 |
| K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN | Icl Scientific | 1979-12-06 |
| K790610 | SIGMOIDOSCOPE TIPLESS | Welch Allyn, Inc. | 1979-04-23 |
| K771815 | SIGMOSCOPE | Dynatech Cryomedical Co. | 1977-10-07 |
| K770291 | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 | Welch Allyn, Inc. | 1977-02-18 |
| K761180 | SIGMOIDOSCOPE/ DISPOSABLE | Smithkline Diagnostics, Inc. | 1977-01-05 |
| K760173 | BRIDGE, SHORT DEFLECTING | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00732094139051 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-18 |
| 00732094139075 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-18 |
| 00732094080940 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094080957 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094080964 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 04961333115303 | PENTAX | HOYA CORPORATION | 2023-07-31 |
| 04547410436501 | FUJIFILM | FUJIFILM CORPORATION | 2021-04-27 |
| 00732094080384 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2021-04-26 |
| 00732094080391 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2021-04-14 |
| 00732094200300 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2020-01-16 |
| 00732094079678 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2018-03-01 |
| 00732094080933 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2018-03-01 |
| 04961333070831 | PENTAX | HOYA CORPORATION | 2017-04-07 |
| 04961333071425 | PENTAX | HOYA CORPORATION | 2017-04-07 |
| 04961333228164 | PENTAX | HOYA CORPORATION | 2017-04-07 |
| 04961333232635 | VIDEO SIGMOIDOSCOPE | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333232642 | VIDEO SIGMOIDOSCOPE | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04547410330977 | FUJIFILM | FUJIFILM CORPORATION | 2016-12-14 |
| 04547410333299 | FUJIFILM | FUJIFILM CORPORATION | 2016-12-14 |
| 04048551084373 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 00732094144024 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-20 |
| 00732094236958 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-20 |
| 00732094106046 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-19 |
| 00732094106060 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094144000 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 50749756173525 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756173520 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |