Robotrac (TM) Retractor Arm
FDA 510(k) K893121 · Aesculap Instruments Corp.
510(k) numberK893121
Submission
- Device name
- Robotrac (TM) Retractor Arm
- Applicant
- Aesculap Instruments Corp.
Burlingame, CA, US - Received
- April 25, 1989
- Decision date
- June 1, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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Questions and answers
When was Robotrac (TM) Retractor Arm cleared by the FDA?
Robotrac (TM) Retractor Arm (K893121) received a 510(k) decision of Substantially Equivalent on June 1, 1989, 37 days after the submission was received.
What is the product code of K893121?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.