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."
25–48 of 182
Search insights Median review: 97d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2025
Vessel Sealer Curved (480522)
K250674 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Jun 11, 2025
da Vinci X Surgical System (IS4200)
K240852 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 440d
Cleared May 13, 2025
SP Endoscope, 0° (430600)
K250786 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Apr 24, 2025
da Vinci SP Surgical System (SP1098)
K243714 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Apr 01, 2025
da Vinci Xi Surgical System (IS4000)
K242427 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 229d
Cleared Mar 10, 2025
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
K243596 · GAG
Intuitive Surgical, Inc.
General & Plastic Surgery · 109d
Cleared Feb 28, 2025
da Vinci SP Advanced Access Port Kit (432701)
K243582 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 100d
Cleared Dec 16, 2024
da Vinci Surgical System (IS5000)
K243641 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 20d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Intuitive Surgical, Inc.
Radiology · 113d
Cleared CT Nov 26, 2024
da Vinci SP Surgical System (SP1098)
K242318 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 113d
Cleared Nov 18, 2024
da Vinci SP Instruments (SP1098)
K241814 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 147d
Cleared Sep 24, 2024
Ion Endoluminal System (IF 1000)
K242070 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 70d
Cleared Sep 10, 2024
8mm SureForm 30 Curved-Tip Stapler
K241638 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 95d
Cleared Aug 05, 2024
Universal Seal (5-12 mm)
K241360 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 83d
Cleared CT Jul 08, 2024
da Vinci SP Surgical System (SP1098)
K240502 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 138d
Cleared Jul 03, 2024
da Vinci Surgical System (IS5000)
K241284 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 57d
Cleared Jun 04, 2024
da Vinci SP Surgical System (SP1098)
K232773 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 267d
Cleared Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
K240135 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 76d
Cleared CT Mar 14, 2024
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with...
K232610 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 199d
Cleared Dec 18, 2023
Ion Endoluminal System (IF1000)
K232984 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Nov 08, 2023
da Vinci SP Surgical System
K231798 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 141d
Cleared Jul 05, 2023
Universal Seal (5-12 mm)
K231358 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 56d
Cleared May 12, 2023
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K231224 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 14d
Cleared Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
K230033 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 90d