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

Solos Endoscopy, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time
50 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983538MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPSolos Endoscopy, Inc.1998-11-06280
K910671MODEL GS-4700 COMMON DUCT STONE REMOVING KITSolos Endoscopy, Inc.1991-05-10840
K900950GS-2000 MICRO SCISSOR, CURVED LEFT, 5MMSolos Endoscopy, Inc.1990-04-18500
K900948GS-1002 GRASPING FORCEP, 5MM WITH RATCHETSolos Endoscopy, Inc.1990-04-18500
K900955GS-4000 REDUCER SLEEVE, 11MM TO 5MMSolos Endoscopy, Inc.1990-04-18500
K900960GS-1500 CLAW FORCEP, 10MMSolos Endoscopy, Inc.1990-04-18500
K900956GS-7100 CHOLANGIOGRAM CLAMP, 5MMSolos Endoscopy, Inc.1990-04-18500
K900965GS-4550 TROCAR ONLY, 11MMSolos Endoscopy, Inc.1990-04-18500
K900947GS-1000 GRASPING FORCEP, 5MM, INSULATEDSolos Endoscopy, Inc.1990-04-18500
K900962GS-4300 CANNULA AND TROCAR, 5.5MMSolos Endoscopy, Inc.1990-04-18500
K900957GS-2100 HOOK SUTURE SCISSOR, 5MMSolos Endoscopy, Inc.1990-04-18500
K900954GS-5200 HOOK SUCTION/COAGULATOR, 5MMSolos Endoscopy, Inc.1990-04-18500
K900953GS-5000 SPATULA SUCTION/COAGULATOR, 5MMSolos Endoscopy, Inc.1990-04-18500
K900952GS-1200 GRASPING/EXTRACTING FORCEP, 10MMSolos Endoscopy, Inc.1990-04-18500
K900958GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MMSolos Endoscopy, Inc.1990-04-18500
K900961GS-4100 REDUCER SLEEVE, 5MM TO 3MMSolos Endoscopy, Inc.1990-04-18500
K900963GS-4350 TROCAR ONLY, 5.5MMSolos Endoscopy, Inc.1990-04-18500
K900959GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATEDSolos Endoscopy, Inc.1990-04-18500
K900964CANNULA AND TROCAR, 11MMSolos Endoscopy, Inc.1990-04-18500
K900949GS-1100 MICRO DISSECTING FORCEP, 5MM, INSULATEDSolos Endoscopy, Inc.1990-04-18500
K900951GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIPSolos Endoscopy, Inc.1990-04-18500

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