Cleared Traditional

K221642 - SIRIUS Endoscope System

K221642 is an FDA 510(k) clearance for SIRIUS Endoscope System, manufactured by Precision Robotics (Hong Kong) Limited. The device is a Class 2 General & Plastic Surgery device with product code HET cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K221642

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
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 172
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