ES-3800, VIDEO SIGMOIDOSCOPE— 510(k) K951577

Clearance details

Applicant

Pentax Precision Instrument Corp.

Product code

Code FAM

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

1995-04-04

Decision date

1996-03-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miramar, FL, US

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• K970382 — VS-100 VIDEO SIGMOIDOSCOPE1997-04-17
• K964326 — VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM1997-01-03
• K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V1001996-12-16
• K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE1996-11-21

• K041395 — EG-3630UR2004-06-09
• K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE2004-06-09
• K041397 — EG-3830UT2004-06-09
• K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE2003-08-08
• K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE2003-02-11

• Z-2075-2016 — Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populationsClass II·Terminated·Pentax Medical Company·20160406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951577.