Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
T. Korossurgical Instruments Corp. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
308 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001915 | GRAFT MARKER RING | T. Korossurgical Instruments Corp. | 2001-04-27 | 308 | 0 |
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | T. Korossurgical Instruments Corp. | 2000-12-04 | 90 | 0 |
| K954016 | VIDEOSCOPE W/IRRIGATION SHEATH | T. Korossurgical Instruments Corp. | 1996-01-25 | 153 | 0 |
| K953998 | DISCETOME TISSUE ASPIRATOR | T. Korossurgical Instruments Corp. | 1995-12-04 | 102 | 0 |
| K954052 | ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES | T. Korossurgical Instruments Corp. | 1995-11-06 | 69 | 0 |
| K954014 | PERCUTANEOUS DISCECTOMY CANNULA SYSTEM | T. Korossurgical Instruments Corp. | 1995-11-06 | 73 | 0 |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1994-03-22 | 126 | 0 |
| K926583 | REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR | T. Korossurgical Instruments Corp. | 1993-08-06 | 322 | 0 |
| K931262 | REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR | T. Korossurgical Instruments Corp. | 1993-08-06 | 151 | 0 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 | 322 | 0 |
| K931259 | ENDOSCOPIC OR THORASCOPIC FORCEPS | T. Korossurgical Instruments Corp. | 1993-06-08 | 88 | 0 |
| K924713 | UNIVERSAL SURGICAL INSTRUMENT HOLDER | T. Korossurgical Instruments Corp. | 1993-05-17 | 241 | 0 |
| K881158 | VASCULAR CLAMP | T. Korossurgical Instruments Corp. | 1988-06-20 | 94 | 0 |
| K881160 | CRANK FRAME RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-06 | 19 | 0 |
| K881157 | STERNUM SPREADER AND MITRAL VALVE RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-06 | 19 | 0 |
| K881159 | I.M.A. RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-05 | 18 | 0 |
| K881156 | UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-05 | 18 | 0 |
| K880998 | STERNUM SPREADER, PEDIATRIC | T. Korossurgical Instruments Corp. | 1988-03-21 | 13 | 0 |
| K880997 | SPRING RETRACTOR | T. Korossurgical Instruments Corp. | 1988-03-21 | 13 | 0 |
| K880813 | SELF-RETAINING SOFT TISSUE RETRACTOR | T. Korossurgical Instruments Corp. | 1988-03-11 | 14 | 0 |
| K880812 | SPINAL NEEDLE | T. Korossurgical Instruments Corp. | 1988-03-11 | 14 | 0 |
| K875290 | LUMBAR IMPACTION SET | T. Korossurgical Instruments Corp. | 1988-03-04 | 65 | 0 |
| K875292 | MICRODISCECTOMY CURETTE SET | T. Korossurgical Instruments Corp. | 1988-01-29 | 30 | 0 |
| K875291 | SPINAL SURGERY FRAME | T. Korossurgical Instruments Corp. | 1988-01-22 | 23 | 0 |
| K875289 | SUCTION RETRACTOR | T. Korossurgical Instruments Corp. | 1988-01-22 | 23 | 0 |
| K850789 | FLUTED SUCTION MENISCAL CUTTER | T. Korossurgical Instruments Corp. | 1985-06-28 | 122 | 0 |
| K850527 | ARTHROSCOPY SUCTION BIOPSY PUNCH | T. Korossurgical Instruments Corp. | 1985-03-14 | 35 | 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