FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURITY ECONOMY II CYSTOSCOPY TRAY
K Number: K820851
·
Decision May 13, 1982
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
63
Review Days
48
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Basic Information
- Device Name
- CURITY ECONOMY II CYSTOSCOPY TRAY
- K Number
- K820851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- The Kendal Co.
- Date Received
- March 26, 1982
- Decision Date
- May 13, 1982
- 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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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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Other Clearances by The Kendal Co.
| K Number | Device Name | ||
|---|---|---|---|
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | Mar 17, 2000 | Substantially Equivalent |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | Sep 28, 1999 | Substantially Equivalent |
| K991758 | MONOJECT INSULIN SYRINGE | Jun 14, 1999 | Substantially Equivalent |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | Apr 23, 1997 | Substantially Equivalent |
| K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | Apr 25, 1995 | Substantially Equivalent |
| K942664 | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM | Jan 17, 1995 | Substantially Equivalent |
| K942774 | POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING | Jul 20, 1994 | Substantially Equivalent for Some Indications |
| K892434 | KENDALL CURITY OXYGEN MASK | Aug 15, 1989 | Substantially Equivalent |
| K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES | Jul 24, 1989 | Substantially Equivalent |
| K892440 | KENDALL CURITY EXTENSION TUBES | Jul 24, 1989 | Substantially Equivalent |