SIM: Gynecologic Power Morcellator And Containment System

FDA product code SIM. Class II, classified under 21 CFR 884.4075. What the classification flags say about Part 820 under the QMSR.

Classification

Product code: SIM
Device name: Gynecologic Power Morcellator And Containment System
Device class: Class II
Regulation: 21 CFR 884.4075
Review panel: Obstetrics/Gynecology
Premarket route: 510(k)
CGMP-exempt flag: No
Life-sustaining flag: No
Implant flag: No
Third-party review: Not a candidate
Summary malfunction reporting: Ineligible

FDA definition. A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery.

Data from openFDA as of 26 October 2026. Read the record on openFDA · FDA product code classification database

Part 820 requirements the flags point to

Part 820 rules for SIM

CGMP exemptionClassification regulation, 21 CFR parts 862 to 892: Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
Design and development, ISO 13485 clause 7.321 CFR 820.10(c): Rule names this classRule names Class II.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.21 CFR 820.10
Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d): Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
Complaint and record content21 CFR 820.35: Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions

These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.

Clearances and recalls on record

510(k), De Novo and BK numbers linked: 1 · Search these clearances
PMA numbers linked: 0
Recall product records: 0
Adverse event reports: Search MAUDE for SIM

Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.

Search all 7,097 product codes, or read the guide to the Part 820 rules behind these flags.

Check your quality documents against Part 820

Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.