Versaport V2 Bladeless Optical Trocar
FDA 510(k) K130435 · Covidien, Formerly US Surgical A Divison of Tyco H
510(k) numberK130435
Submission
- Device name
- Versaport V2 Bladeless Optical Trocar
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
North Haven, CT, US - Received
- February 21, 2013
- Decision date
- March 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
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| K121510 | Idrive Ultra Powered Handle Endo Gia AdapterGDW · Traditional | 07/25/2012SE |
| K120061 | Wound ProtectorGCJ · Traditional | 03/27/2012SE |
| K120258 | Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…GDW · Traditional | 02/29/2012SE |
| K111825 | Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) StaplersGDW · Traditional | 10/25/2011SE |
| K112349 | Versaport V2 Bladeless Optiical Trocar And/Or Versaport Bladeless Optical TrocarGCJ · Special | 09/01/2011SE |
Questions and answers
When was Versaport V2 Bladeless Optical Trocar cleared by the FDA?
Versaport V2 Bladeless Optical Trocar (K130435) received a 510(k) decision of Substantially Equivalent on March 14, 2013, 21 days after the submission was received.
What is the product code of K130435?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.