8MM TROCAR KIT— 510(k) K133845
Substantially EquivalentIntuitive Surgical
FDA 510(k) clearance K133845 for 8MM TROCAR KIT, Substantially Equivalent on 2014-02-19. Applicant: Intuitive Surgical. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code GCJ
view allMore clearances from Intuitive Surgical
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K133845
K-number listed on FDA's recall record- Z-2038-2016 — SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
- Z-1836-2016 — SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133845.
Data sourced from openFDA. This site is unofficial and independent of the FDA.