Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.
This document outlines the information to be submitted in a 510(k) premarket notification for hysteroscopes and gynecologic laparoscopes. For devices that differ significantly from those already on the market, FDA may require additional information specific to those differences. This document is intended as a companion to the Substantial Equivalence Comparison Chart released in April 1995 (see Appendix A), and it replaces our previous March 25, 1994, “Hysteroscopes & Laparoscopes, Insufflators & Other Related Instrumentation: Submission Requirements for a 510(k).”
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.