Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

182 results for "Intuitive Surgical, Inc."
1–24 of 182
Search insights Median review: 97d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2026
da Vinci Xi Surgical System (IS4000)
K263592 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Oct 14, 2026
da Vinci 5 Handheld Camera Head (470080)
K262455 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Sep 08, 2026
da Vinci Surgical System, Model IS5000
K261823 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Aug 07, 2026
Intuitive Endoluminal Gastrointestinal System (IG1000)
K253702 · FDS
Intuitive Surgical, Inc.
Gastroenterology & Urology · 256d
Cleared Jul 31, 2026
da Vinci Surgical System, Model IS5000
K261824 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Jul 14, 2026
Universal Seal (5-12 mm)
K261249 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 11, 2026
da Vinci Force Feedback Instruments
K253986 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Feb 24, 2026
Universal Seal (5-12 mm)
K253978 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Jan 16, 2026
da Vinci SP Surgical System (SP1098)
K253556 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 63d
Cleared Jan 16, 2026
da Vinci Surgical System (IS5000)
K251739 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 224d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 15, 2025
da Vinci SP Surgical System (SP1098)
K252675 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Dec 02, 2025
da Vinci SP Surgical System (SP1098)
K252069 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 154d
Cleared Oct 03, 2025
da Vinci SP Surgical System (SP1098)
K251426 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Sep 23, 2025
Ion Endoluminal System (IF1000)
K252045 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 10, 2025
da Vinci SP Surgical System (SP1098)
K251817 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Sep 08, 2025
da Vinci Surgical System (IS5000)
K251227 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Sep 05, 2025
Ion Endoluminal System (IF1000)
K252528 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 29, 2025
da Vinci SP Surgical System (SP1098)
K251324 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 122d
Cleared Aug 28, 2025
da Vinci SP Firefly Imaging System
K252350 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Jul 29, 2025
da Vinci Surgical System, IS5000
K250442 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 165d
Cleared Jul 23, 2025
Da Vinci Surgical System (IS5000)
K251213 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 96d
Cleared Jul 16, 2025
da Vinci Surgical System (IS5000)
K251202 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 02, 2025
8 mm Assist Cannula
K251490 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 49d