Atlas FDA

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

Surgi-Vision, Inc. — Predicate Candidate Screening

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

70 daysmedian FDA review time
88 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K111073SURGIVISION INC. CLEARPOINT SYSTEMSurgi-Vision, Inc.2011-06-22650
K020790INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MISurgi-Vision, Inc.2002-05-21710
K020495INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INSurgi-Vision, Inc.2002-04-23680
K011781INTERCEPT-URETHRAL MICROCOILSurgi-Vision, Inc.2001-08-31850
K003436SURGI-VISION GUIDEWIRE COILSurgi-Vision, Inc.2001-02-02880
K002916SURGI-VISION PROSTATE COILSurgi-Vision, Inc.2000-11-28700
K002345SURGI-VISION URETHRAL COILSurgi-Vision, Inc.2000-10-11700
K994436SURGI-VISION ESOPHAGEAL STYLET COILSurgi-Vision, Inc.2000-03-14750
K992193ENDO-ESOPHAGEAL MR COILSurgi-Vision, Inc.1999-09-03660

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