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

Novare Surgical Systems, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time
515 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K072715REALHAND HIGH DEXTERITY INSTRUMENTSNovare Surgical Systems, Inc.2007-10-16210
K071488REALHAND HIGH DEXTERITY (HD) INSTRUMENTSNovare Surgical Systems, Inc.2007-06-29300
K043541ENDOLINK TRUE MOVEMENT SYSTEMNovare Surgical Systems, Inc.2005-03-10780
K032589ENCLOSE II ANASTOMOSIS ASSIST DEVICENovare Surgical Systems, Inc.2003-09-05140
K023682ENCLOSE ANASTOMOSIS ASSIST DEVICENovare Surgical Systems, Inc.2003-01-16760
K010727FLEXLINE CLAMPNovare Surgical Systems, Inc.2002-08-095150
K010694INCLUDER CLAMPNovare Surgical Systems, Inc.2002-02-113400
K992980ENGAGE JAW INSERTSNovare Surgical Systems, Inc.2000-06-082790
K000098SOFTLINE SPRING CLIPNovare Surgical Systems, Inc.2000-04-12900

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