Cleared Traditional

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles

K210946 · Promisemed Hangzhou Meditech Co., Ltd. · General & Plastic Surgery
Aug 2021
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K210946 is an FDA 510(k) clearance for the Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on August 12, 2021, 135 days after receiving the submission on March 30, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K210946 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2021
Decision Date August 12, 2021
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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