FDA Product Code
FDA Product Code FAM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964131 | ENDOSCOPE | Akos Biomedical, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K970382 | VS-100 VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | 1997-04-17 | Traditional | PDF ↗ |
| K964326 | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 1997-01-03 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K963344 | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE | Vision-Sciences, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K961567 | ES-3840, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-06-24 | Traditional | PDF ↗ |
| K951577 | ES-3800, VIDEO SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | Traditional | PDF ↗ |
| K950429 | VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | 1995-08-01 | Traditional | PDF ↗ |
| K951576 | FS-34P2, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-29 | Traditional | PDF ↗ |
| K951573 | FS-38H, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | Traditional | PDF ↗ |
| K951572 | FS-38X, FIBER SIGMOIDOSCOPE | Pentax Precision Instrument Corp. | 1995-06-27 | Traditional | PDF ↗ |
| K932843 | FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH | Vision-Sciences, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | Vision-Sciences, Inc. | 1992-10-28 | Traditional | PDF ↗ |
| K892000 | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE | Schott Fiber Optics, Inc. | 1989-04-25 | Traditional | PDF ↗ |
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | Harvard Laboratories | 1982-11-17 | Traditional | PDF ↗ |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | American Optical Corp. | 1982-04-01 | Traditional | PDF ↗ |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | American Optical Corp. | 1981-11-02 | Traditional | PDF ↗ |
| K792341 | PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34 | Pentax Precision Instrument Corp. | 1979-12-10 | Traditional | PDF ↗ |
| K792314 | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN | Icl Scientific | 1979-12-06 | Traditional | PDF ↗ |
| K790610 | SIGMOIDOSCOPE TIPLESS | Welch Allyn, Inc. | 1979-04-23 | Traditional | PDF ↗ |
| K771815 | SIGMOSCOPE | Dynatech Cryomedical Co. | 1977-10-07 | Traditional | PDF ↗ |
| K770291 | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 | Welch Allyn, Inc. | 1977-02-18 | Traditional | PDF ↗ |
| K761180 | SIGMOIDOSCOPE/ DISPOSABLE | Smithkline Diagnostics, Inc. | 1977-01-05 | Traditional | PDF ↗ |
| K760173 | BRIDGE, SHORT DEFLECTING | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 | Traditional | PDF ↗ |
Product code FAM · Class II · Gastroenterology, Urology. Data: openFDA.