FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYSTOSCOPES
K Number: K003807
·
Decision Feb 22, 2001
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
7
Review Days
76
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CYSTOSCOPES
- K Number
- K003807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Global Endoscopy, Inc.
- Date Received
- December 8, 2000
- Decision Date
- February 22, 2001
- 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,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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°,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PrimeSight UltraView System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UV5000W Handle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Global Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003805 | GYNECOLOGICAL LAPAROSCOPES | Jul 22, 2001 | Substantially Equivalent |
| K003802 | HYSTEROSCOPES | Jul 22, 2001 | Substantially Equivalent |
| K003831 | ARTHROSCOPES | Jul 20, 2001 | Substantially Equivalent |
| K003830 | ENT ENDOSCOPES | Apr 9, 2001 | Substantially Equivalent |
| K003803 | GENERAL SURGICAL LAPAROSCOPES | Mar 7, 2001 | Substantially Equivalent |
| K003806 | URETEROSCOPES | Feb 22, 2001 | Substantially Equivalent |