FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K Number: K914008
·
Decision Jan 10, 1992
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
67
Review Days
123
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Basic Information
- Device Name
- PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
- K Number
- K914008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pentax Precision Instrument Corp.
- Date Received
- September 9, 1991
- Decision Date
- January 10, 1992
- Product Code
- FAJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAJ), ordered by most recent decision date.
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,
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FDA Class 2
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Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
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Other Clearances by Pentax Precision Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Jun 9, 2004 | Substantially Equivalent |
| K041395 | EG-3630UR | Jun 9, 2004 | Substantially Equivalent |
| K041397 | EG-3830UT | Jun 9, 2004 | Substantially Equivalent |
| K031789 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Aug 8, 2003 | Substantially Equivalent |
| K023401 | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE | Feb 11, 2003 | Substantially Equivalent |
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE | Oct 16, 2002 | Substantially Equivalent |
| K021276 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Sep 12, 2002 | Substantially Equivalent |
| K021278 | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE | Sep 6, 2002 | Substantially Equivalent |
| K013640 | EG-3630UR, ULTRASUND VIDEO GASTROSCOPE | Feb 4, 2002 | Substantially Equivalent |
| K010740 | FG-36UX, FIBER ULTRASOUND GASTROSCOPE | Apr 17, 2001 | Substantially Equivalent |