Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Interlace Medical, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

95 daysmedian FDA review time
190 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103741SURGISURE TISSUE REMOVAL SYSTEMInterlace Medical, Inc.2011-03-02690
K102686MYOSURE ROD LENS SCOPE SEALSInterlace Medical, Inc.2010-10-15280
K100559MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMInterlace Medical, Inc.2010-03-30290
K091100MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMInterlace Medical, Inc.2009-10-231900
K091465MYOSURE ROD LENS HYSTEROSCOPEInterlace Medical, Inc.2009-08-21950
K081070INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEMInterlace Medical, Inc.2008-07-23990
K073690INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEMInterlace Medical, Inc.2008-04-171110

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda