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

Coalescent Surgical · Predicate Candidate Screening

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

47 daysmedian FDA review time

90 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040821	COALESCENT SURGICAL U-CLIP AND ACCESSORIES	Coalescent Surgical	2004-04-23	24	0
K031623	MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES	Coalescent Surgical	2003-07-03	41	4
K024366	COALESCENT SURGICAL U-CLIP AND ACCESSORIES	Coalescent Surgical	2003-01-17	17	1
K023125	COALESCENT U-CLIP- AND ACCESSORIES	Coalescent Surgical	2002-12-18	90	0
K021407	COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES	Coalescent Surgical	2002-07-03	61	0
K013664	COALESCENT SURGICAL U-CLIP	Coalescent Surgical	2002-01-24	79	0
K012317	COALESCENT SURGICAL U-CLIP	Coalescent Surgical	2001-08-31	39	0
K003958	COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE	Coalescent Surgical	2001-02-06	47	0
K994160	COALESCENT SURGICAL SUTURED-CLIP	Coalescent Surgical	2000-02-04	57	0

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