Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Surgical Instrument Services and Savings, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | 2023-12-15 | 151 | 2 |
| K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open | Surgical Instrument Services and Savings, Inc. | 2017-05-01 | 213 | 1 |
| K152313 | Medline ReNewal Reprocessed Endopath Endoscopic Instruments | Surgical Instrument Services and Savings, Inc. | 2016-01-06 | 142 | 0 |
| K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without A | Surgical Instrument Services and Savings, Inc. | 2015-12-16 | 289 | 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