510(k) K895643
- Device
- MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
- Applicant
- ORTHOCONCEPT, INC.
- 510(k) number
- K895643
- Product code
- FDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-17
- Date received
- 1989-08-28
- Regulation
- 876.1500
- Classification name
- Resectoscope, Working Element
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK DEFRANCO
- Address
- 8 Cold Branch Ct. Columbia SC US 29223 29223
FDA Registration Numbers#
- 3006546082
- 8043746
- 3013247477
- 2431166
- 9610617
- 3010202439
- 1649518
- 9611102
- 2020550
- 9610773
- 3002807310
- 2243757
- 9610614
- 3011050570
- 3014342096
- 9680515
- 3010383847
- 3012322232
- 1057358
- 3004111573
- 3013011598
- 1418479
- 8010418
- 2936485
- 2424366
- 3009217531
- 3024021261
- 1221934
- 3031240334
- 3010707607
- 3015895045
- 9617070
- 3015286855
- 2183744
- 2085947
- 1519132
- 3003790304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FDC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021166 | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR | Acmi-Circon Corporation | 2002-05-09 |
| K992141 | OLYMPUS WORKING ELEMENT FOR PROBES | Olympus Winter & Ibe GmbH | 1999-09-29 |
| K991426 | MAHE INSTRUMENTS | Mahe Intl., Inc. | 1999-08-05 |
| K942626 | CONTINUOUS FLOW BIOPSY PROBE | Gm Engineering, Inc. | 1995-05-30 |
| K933962 | GM CONTINUOUS FLOW BIOPSY PROBE | Gm Engineering, Inc. | 1994-02-25 |
| K894363 | UROPUMP* FLUID MANAGEMENT SYSTEM | Orthoconcept, Inc. | 1989-08-11 |
| K842997 | LASER RECTOSCOPE SET 784 | Laser Industries , Ltd. | 1984-08-27 |
| K760182 | SHEATH, RESECTOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| K760184 | ELEMENT, WORKING | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| K760174 | ADAPTER, RESECTOSCOPE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |
Legacy Summary#
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FDA Review#
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