WHERE ARE YOU?

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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K261196

510(k) cleared

Promisemed VeriEcto Automatic Biopsy Needles

Promisemed Hangzhou Meditech Co., Ltd. · May 12, 2026 · K261196

FDA cleared the Promisemed VeriEcto Automatic Biopsy Needles from Promisemed Hangzhou Meditech Co., Ltd. on May 12, 2026 under K261196, a special 510(k). The device falls under product code KNW, Instrument, Biopsy, regulated at 21 CFR 876.1075 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 13, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Promisemed Hangzhou Meditech Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261045 (Verifine Safety Lancets), K254273 (Verisafe Safety Sterile Needles (SSN)), K250192 (Verisafe Safety Retractable Insulin Syringes).

Questions & Answers

What did FDA clear under K261196?

K261196 is the FDA 510(k) for Promisemed VeriEcto Automatic Biopsy Needles, submitted by Promisemed Hangzhou Meditech Co., Ltd.. FDA's decision date was May 12, 2026, under product code KNW (Instrument, Biopsy).

Who makes the Promisemed VeriEcto Automatic Biopsy Needles?

Promisemed Hangzhou Meditech Co., Ltd., based in Hangzhou City, is the applicant of record for K261196.

How long did the K261196 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on May 12, 2026, 29 days later.

← All decisions in May 2026

Sources