Cleared Traditional

K210116 - Video Endoscopy System, 3D Video Endoscopy System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210116 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
267d
Days
Class 2
Risk

K210116 is an FDA 510(k) clearance for the Video Endoscopy System, 3D Video Endoscopy System. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on October 13, 2021 after a review of 267 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. devices

Submission Details

510(k) Number K210116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date October 13, 2021
Days to Decision 267 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 160d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K210116.
SIRIUS Endoscope System (PR-SI-1230)
K250939 · Precision Robotics (Hong Kong) Limited · Aug 2025
i-Cut
K243821 · A.M.I. Agency For Medical Innovations GmbH · Apr 2025
SIRIUS Endoscope System
K221642 · Precision Robotics (Hong Kong) Limited · Dec 2022
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K201832 · Olympus Medical Systems Corp. · Sep 2021
SurroundScope System
K210104 · 270surgical , Ltd. · Jul 2021
TipVision Videoscope System (TipVision VideoScope 0°/30°
K201617 · Schoelly Fiberoptic GmbH · Mar 2021