Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003
FDA 510(k) K090902 · Transenterix, Inc.
510(k) numberK090902
Submission
- Device name
- Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003
- Applicant
- Transenterix, Inc.
Durham, NC, US - Received
- April 1, 2009
- Decision date
- July 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003 cleared by the FDA?
Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003 (K090902) received a 510(k) decision of Substantially Equivalent on July 22, 2009, 112 days after the submission was received.
What is the product code of K090902?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.