FS-38X, FIBER SIGMOIDOSCOPE— 510(k) K951572
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K951572 for FS-38X, FIBER SIGMOIDOSCOPE, Substantially Equivalent on 1995-06-27. Applicant: Pentax Precision Instrument Corp.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miramar, FL, US
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More clearances from Pentax Precision Instrument Corp.
view allRecalls naming K951572
K-number listed on FDA's recall record- 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 populations
- Z-2280-2016 — Signmoidoscope Product Usage: 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 populations.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.