Cleared Traditional

K221642 - SIRIUS Endoscope System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221642 · Precision Robotics (Hong Kong) Limited · General & Plastic Surgery device
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Dec 2022
Decision
189d
Days
Class 2
Risk

K221642 is an FDA 510(k) clearance for the SIRIUS Endoscope System. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Precision Robotics (Hong Kong) Limited (Hong Kong, CN). The FDA issued a Cleared decision on December 12, 2022 after a review of 189 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 884.1720 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Robotics (Hong Kong) Limited devices

Submission Details

510(k) Number K221642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date December 12, 2022
Days to Decision 189 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 114d · This submission: 189d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Vee Care (Asia) Limited
Sharon Hsu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K221642.
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
Video Endoscopy System, 3D Video Endoscopy System
K210116 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2021
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