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

Surgical Specialties Corp — Predicate Candidate Screening

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

44 daysmedian FDA review time
98 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141625POLYSYN SURGICAL SUTURESurgical Specialties Corp2014-07-18310
K141558QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICESurgical Specialties Corp2014-07-11290
K140227MONODERM SURGICAL SUTURESurgical Specialties Corp2014-02-28290
K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONESurgical Specialties Corp2008-04-23160
K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXSurgical Specialties Corp2008-03-21110
K071989QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGISurgical Specialties Corp2007-08-06170
K072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERMSurgical Specialties Corp2007-08-03100
K063680SHARPOINT PDO (POLYDIOXANONE) SUTURESSurgical Specialties Corp2007-05-091490
K053380CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURESurgical Specialties Corp2006-01-18440
K052962OPTIMIZED BARB DESIGNSurgical Specialties Corp2005-12-06460
K052437MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURESurgical Specialties Corp2005-11-07620
K050548CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADSSurgical Specialties Corp2005-04-01300
K050292SHARPOINT LUKENS BONE WAXSurgical Specialties Corp2005-03-09300
K050247CONTOUR NECKLIFT THREADSSurgical Specialties Corp2005-03-04300
K042856CONTOUR FOREHEAD/BROWLIFT THREADSurgical Specialties Corp2004-12-03600
K041593FEATHERLIFT EXTENDED LENGTH APTOS THREADSurgical Specialties Corp2004-09-20980
K040477MONODERMSurgical Specialties Corp2004-05-18840
K020882SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGSurgical Specialties Corp2002-07-261300
K014021SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETICSurgical Specialties Corp2002-01-28530
K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDSurgical Specialties Corp2000-12-15790
K002849PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, ANDSurgical Specialties Corp2000-10-18350
K001765LOOK COLLAGEN SPACERS, MODEL 1514BSurgical Specialties Corp2000-09-07870

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