WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K262455

510(k) cleared

da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System

Intuitive Surgical, Inc. · Oct 14, 2026 · K262455

FDA cleared the da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System from Intuitive Surgical, Inc. on Oct 14, 2026 under K262455, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 17, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Intuitive Surgical, Inc. has 8 other decisions in the tracker over the last 12 months: K261823 (da Vinci Surgical System, Model IS5000), K253702 (Intuitive Endoluminal Gastrointestinal System (IG1000)), K261824 (da Vinci Surgical System, Model IS5000), K261249 (Universal Seal (5-12 mm)).

Questions & Answers

What did FDA clear under K262455?

K262455 is the FDA 510(k) for da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System, submitted by Intuitive Surgical, Inc.. FDA's decision date was Oct 14, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System?

Intuitive Surgical, Inc., based in Sunnyvale, CA, is the applicant of record for K262455.

How long did the K262455 review take?

FDA received the submission on Jul 17, 2026 and issued its decision on Oct 14, 2026, 89 days later.

← All decisions in October 2026