510(k) K870679
- Device
- VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
- Applicant
- VAN-TEC, INC.
- 510(k) number
- K870679
- Product code
- FBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-30
- Date received
- 1987-02-19
- Regulation
- 876.1500
- Classification name
- Cystourethroscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES F VANCE
- Address
- P.O. Box 26 Spencer IN US 47460 47460
FDA Registration Numbers#
- 3005465238
- 3006546082
- 3013247477
- 9610617
- 8010047
- 3010202439
- 9611102
- 2020550
- 3007055279
- 3014342096
- 3011050570
- 1221826
- 3012322232
- 3004644065
- 3014279513
- 1418479
- 3001614464
- 3010707607
- 9614434
- 9610595
- 1519132
- 3003790304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FBO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & CO. KG | 2025-05-02 |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | 2024-11-27 |
| K131364 | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 2014-01-02 |
| K082046 | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO | KARL STORZ Endoscopy-America, Inc. | 2008-10-10 |
| K080780 | ANCHORAGE SCOPE, MODEL 000003 | Epitek, Inc. | 2008-07-30 |
| K062918 | KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2007-01-17 |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | Laserscope | 2006-06-27 |
| K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 | Richard Wolf Medical Instruments Corp. | 2001-08-10 |
| K972979 | SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM | Smith & Nephew, Inc. | 1997-12-11 |
| K962474 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) | Olympus America, Inc. | 1996-12-20 |
| K941992 | CYSTOSCOPE | Surgical Technologies, Inc. | 1995-11-30 |
| K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | Cabot Medical Corp. | 1995-07-21 |
| K945185 | CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) | KARL STORZ Endoscopy-America, Inc. | 1995-05-03 |
| K934649 | GALILEO ENDOSCOPES | Galileo Electro-Optics Corp. | 1994-10-13 |
| K943668 | KSEA CONTINOUS FLOW CYSTOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-21 |
Legacy Summary#
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FDA Review#
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