Cleared Traditional

Gas Insufflator

K221995 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Obstetrics & Gynecology
Mar 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K221995 is an FDA 510(k) clearance for the Gas Insufflator, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on March 28, 2023, 265 days after receiving the submission on July 6, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number K221995 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2022
Decision Date March 28, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIF — Insufflator, Laparoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1730

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