Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Surgical, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
297 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950126 | ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDG | Advanced Surgical, Inc. | 1995-04-13 | 91 | 0 |
| K950005 | TROCAR CANNULA STABILIZER | Advanced Surgical, Inc. | 1995-01-18 | 15 | 0 |
| K945369 | LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE | Advanced Surgical, Inc. | 1994-11-22 | 89 | 0 |
| K933497 | LAPAROSCOPIC COVERED SURGICAL RETRACTOR | Advanced Surgical, Inc. | 1994-05-12 | 297 | 0 |
| K941500 | TISSUE ISOLATION AND RETRIEVAL BAG | Advanced Surgical, Inc. | 1994-04-19 | 21 | 0 |
| K931850 | VERRSS PNEUMO NEEDLE | Advanced Surgical, Inc. | 1994-04-07 | 359 | 0 |
| K934807 | PUNCTURE CLOSURE DEVICE | Advanced Surgical, Inc. | 1994-03-01 | 145 | 0 |
| K932540 | LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE | Advanced Surgical, Inc. | 1994-02-17 | 267 | 0 |
| K940193 | SURGICAL RETRACTOR KIT | Advanced Surgical, Inc. | 1994-02-15 | 33 | 0 |
| K935878 | GLASSER SUTURE NEEDLE | Advanced Surgical, Inc. | 1994-02-09 | 62 | 0 |
| K933812 | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSOR | Advanced Surgical, Inc. | 1993-12-13 | 131 | 0 |
| K933243 | KNOT PUSHER | Advanced Surgical, Inc. | 1993-10-21 | 111 | 0 |
| K933032 | LAPAROSCOPIC SURGICAL RETRACTOR | Advanced Surgical, Inc. | 1993-09-09 | 79 | 0 |
| K931886 | TISSUE ISOLATION AND RETRIEVAL BAG | Advanced Surgical, Inc. | 1993-09-07 | 145 | 0 |
| K933009 | SURGICAL RETRACTOR/BLUNT DISSECTOR | Advanced Surgical, Inc. | 1993-09-03 | 74 | 0 |
| K933049 | SRUGICAL RETRACTOR, MODIFICATION | Advanced Surgical, Inc. | 1993-08-24 | 99 | 0 |
| K930787 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT | Advanced Surgical, Inc. | 1993-07-09 | 143 | 0 |
| K921287 | SURGICAL RETRACTOR | Advanced Surgical, Inc. | 1993-03-04 | 352 | 0 |
| K924728 | KNOT PUSHER | Advanced Surgical, Inc. | 1992-12-29 | 99 | 0 |
| K922435 | LAPAROSCOPIC CURVED TRIANGLE RETRACTOR | Advanced Surgical, Inc. | 1992-12-24 | 216 | 0 |
| K922190 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Advanced Surgical, Inc. | 1992-10-23 | 165 | 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