FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
K Number: K895182
·
Decision Oct 24, 1989
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
9
Review Days
74
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Basic Information
- Device Name
- ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
- K Number
- K895182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Surgical Intervention, Inc.
- Date Received
- August 11, 1989
- Decision Date
- October 24, 1989
- 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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CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
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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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FDA Class 2
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PrimeSight UltraView System
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FDA 510(k)
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Other Clearances by Advanced Surgical Intervention, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954215 | MINIGUARD | May 8, 1996 | Substantially Equivalent |
| K926110 | ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT | Jul 8, 1993 | Substantially Equivalent |
| K930361 | ASI CYSTOLASE LASER CYSTOSCOPE | Apr 29, 1993 | Substantially Equivalent |
| K921990 | ASI UROPLASTY LASER CYSTOSCOPE | Oct 28, 1992 | Substantially Equivalent |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | Aug 27, 1990 | Substantially Equivalent |
| K901336 | ASI HEMOSTASIS CATHETER | Jun 20, 1990 | Substantially Equivalent |
| K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | May 24, 1990 | Substantially Equivalent |
| K874530 | URETHRAL DILATOR ENDOSCOPE | Jan 27, 1988 | Substantially Equivalent |