IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps— 510(k) K150837
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K150837 for IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps, Substantially Equivalent on 2015-04-29. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code NAY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code NAY
view allMore clearances from Intuitive Surgical, Inc.
view allAdverse events under product code NAY
product code NAY- Death
- 433
- Injury
- 7,927
- Malfunction
- 93,790
- Other
- 19
- Total
- 102,169
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 K150837
K-number listed on FDA's recall record- Z-0870-2025 — 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
- Z-0882-2025 — 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
- Z-1460-2022 — Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150837.
Data sourced from openFDA. This site is unofficial and independent of the FDA.