Endex Endoscopic Positioning System
FDA 510(k) K936308 · Andronic Devices, Ltd.
510(k) numberK936308
Submission
- Device name
- Endex Endoscopic Positioning System
- Applicant
- Andronic Devices, Ltd.
Richmond, B.C. Canada V6v 2j2, CA - Received
- December 20, 1993
- Decision date
- March 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K240598 | Maestro System (REF100)FQO · Traditional | Moon Surgical | 06/03/2024SE |
| K221410 | Maestro PlatformFQO · Traditional | Moon Surgical | 12/02/2022SE |
| K090136 | Steris Cmax XLT Surgical TableFQO · Traditional | STERIS Corporation | 03/20/2009SE |
| K972810 | OPT80 the Transportable (OPT80)FQO · Traditional | O.P.T. USA, Inc. | 08/26/1997SE |
| K971988 | Allen, Ultra and Smart SocketsFQO · Traditional | Allen Medical Systems, Inc. | 07/11/1997SE |
| K971307 | Amsco Surgical TableFQO · Traditional | STERIS Corporation | 06/27/1997SE |
| K963506 | Tenet Radiolucent Hand TableFQO · Traditional | Tenet Medical Engineering | 01/09/1997SE |
| K961886 | Drager Gemina Wall-Mounted WorkplaceFQO · Traditional | Alm Surgical Equipment, Inc. | 07/30/1996SE |
| K961742 | Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional | Alm Surgical Equipment, Inc. | 07/26/1996SE |
| K955750 | TeletomFQO · Traditional | Berchtold Holding GmbH | 02/08/1996SE |
More from Berchtold Holding GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | 11/21/1994SE |
| K934928 | Insite Filter & Tubing SetHIF · Traditional | 05/26/1994SE |
| K934926 | Insite Model 20 & Model 15 InsufflatorsHIF · Traditional | 05/26/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | 04/15/1994SE |
| K934124 | Autoquot Automated Aliquotting SystemJQW · Traditional | 04/13/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | 10/19/1992SE |
| K911521 | Arthrobot(Tm) 96 (240 CM) Drape with 1 StrapKKX · Traditional | 08/02/1991SE |
| K911520 | Arthrobot(Tm) 75 (190 CM) General Purpose DrapeKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Endex Endoscopic Positioning System cleared by the FDA?
Endex Endoscopic Positioning System (K936308) received a 510(k) decision of Substantially Equivalent on March 31, 1994, 101 days after the submission was received.
What is the product code of K936308?
The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.