Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003
K090902 is the FDA 510(k) clearance record for SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003, a class II device, cleared for Transenterix, Inc. on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "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...". FDA records list 21 510(k) clearances for Asensus Surgical, Inc., from to . As of , FDA records show one recall naming K090902.
Clearance record
- Decision date
- Received
- (112 days to decision)
- Product code
- GCJ Laparoscope, General & Plastic Surgery
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Applicant
- Transenterix, Inc. 3908 Patriot Dr. Suite 170, Durham NC
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code GCJ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 0 |
| January 2026 | 3 |
| February 2026 | 4 |
| March 2026 | 0 |
| April 2026 | 3 |
| May 2026 | 4 |
| June 2026 | 4 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 2 |
| October 2026 | 0 |
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