Adept Endoscopic Positioner
FDA 510(k) K922625 · Andronic Devices, Ltd.
510(k) numberK922625
Submission
- Device name
- Adept Endoscopic Positioner
- Applicant
- Andronic Devices, Ltd.
Richmond,B.C. V6v-2j2, CA - Received
- June 3, 1992
- Decision date
- October 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K152538 | JRP Wound SpreaderGAD · Traditional | J.R. Parker, LLC | 04/13/2016SE |
| K151104 | Otelo LLGAD · Traditional | Spineart | 01/06/2016SE |
| K132645 | Thoratrak Mics Retractor System, Rack, BladesGAD · Traditional | Medtronic, Inc. | 10/04/2013SE |
| K071775 | DashGAD · Traditional | Ezsurgical | 08/07/2007SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | Apple Medical Corp. | 04/26/2005SE |
| K043602 | Quadrant Retractor SystemGAD · Traditional | Medtronic Sofamor Danek | 02/23/2005SE |
| K001339 | MRI Fastsystem Retractor SystemGAD · Special | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 05/17/2000SE |
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | Clarus Medical Systems, Inc. | 08/18/1998SE |
| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
| K943875 | Villalta RetractorGAD · Traditional | Hct, Inc. | 11/09/1994SE |
More from Hct, Inc.
| 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 |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | 03/31/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · 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 Adept Endoscopic Positioner cleared by the FDA?
Adept Endoscopic Positioner (K922625) received a 510(k) decision of Substantially Equivalent on October 19, 1992, 138 days after the submission was received.
What is the product code of K922625?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.