Product Classification

• Device: laparoscope, gynecologic (and accessories)
• Regulation Description: Gynecologic laparoscope and accessories.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: HET
• Submission Type: 510(k)
• Regulation Number: 884.1720
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 8600-5 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
• ISO 8600-6 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
• ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and optical instruments - Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics`
• IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
• ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
• ISO 8600-4 First edition 1997-07-01 Optics and optical instruments -- Medical endoscopes and certain accessories -- Part 4: Determination of maximum width of insertion portion
• ISO 8600-1 Second edition 2005-05-01 Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 1: General requirements
• IEC 60601-2-18 (1996) Amendment 1 2000 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment

Guidance Document

• Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.