Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Products Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
320 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921671 | SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE | Surgical Products Corp. | 1992-06-18 | 71 | 0 |
| K861614 | GHI WET PENCIL | Surgical Products Corp. | 1986-07-08 | 70 | 0 |
| K841241 | ANTERIOR CRUCIATE LIGAMENT GRASPER | Surgical Products Corp. | 1985-02-06 | 320 | 0 |
| K841247 | SPC DISPOSABLE CUTTER | Surgical Products Corp. | 1984-05-02 | 42 | 0 |
| K841328 | SPC ARTHROSCOPY TABLE | Surgical Products Corp. | 1984-05-02 | 50 | 0 |
| K834434 | MACH I ELECTROSURGERY HAND CONTROL | Surgical Products Corp. | 1984-04-25 | 128 | 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