510(k) K961567
- Device
- ES-3840, VIDEO SIGMOIDOSCOPE
- Applicant
- PENTAX PRECISION INSTRUMENT CORP.
- 510(k) number
- K961567
- Product code
- FAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-24
- Date received
- 1996-04-23
- Regulation
- 876.1500
- Classification name
- Sigmoidoscope And Accessories, Flexible/rigid
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL SILVA
- Address
- 3117 Commerce Pkwy. Miramar FL US 33025 33025
FDA Registration Numbers#
- 3006546082
- 3003782610
- 3013557562
- 9611112
- 3042225166
- 1055236
- 9610877
- 9610617
- 3013298431
- 3010202439
- 1316463
- 2020550
- 3014579161
- 3006161756
- 3014342096
- 1221826
- 3000268902
- 3004644065
- 1043214
- 3012421607
- 3010405378
- 3014605202
- 3012494290
- 3001124136
- 2320762
- 1054241
- 3010707607
- 3004450489
Source Documents#
Other 510(k) Records For Product Code FAM #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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