Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marlo Surgical Technology — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
268 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960810 | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/1 | Marlo Surgical Technology | 1996-10-21 | 236 | 0 |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Marlo Surgical Technology | 1996-07-31 | 48 | 0 |
| K924611 | IRRIGATION PUMP AND TUBING SET | Marlo Surgical Technology | 1994-06-30 | 657 | 0 |
| K932832 | PRIMUS INSULATED FORCEPS | Marlo Surgical Technology | 1994-02-25 | 261 | 0 |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | Marlo Surgical Technology | 1994-02-25 | 268 | 0 |
| K920611 | MARLOW LAPAROSCOPIC GRASPING FORCEP | Marlo Surgical Technology | 1993-04-20 | 434 | 0 |
| K914153 | OTT INSUFFLATOR FILTER PLUS/TUBING SET | Marlo Surgical Technology | 1992-04-02 | 199 | 0 |
| K914869 | MARLOW LAPAROSCOPIC SCISSORS | Marlo Surgical Technology | 1992-01-15 | 78 | 0 |
| K913954 | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS | Marlo Surgical Technology | 1991-12-18 | 104 | 0 |
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | Marlo Surgical Technology | 1991-11-19 | 21 | 0 |
| K913964 | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | Marlo Surgical Technology | 1991-10-23 | 48 | 0 |
| K913586 | MARLOW VERRES NEEDLES | Marlo Surgical Technology | 1991-10-08 | 57 | 0 |
| K911164 | REICH SUCTION/IRRIGATION CANNULA | Marlo Surgical Technology | 1991-07-05 | 112 | 0 |
| K911149 | PAL (PROBE FOR ASPIRATION AND LAVAGE) | Marlo Surgical Technology | 1991-07-05 | 112 | 0 |
| K910907 | PUMP VAC PLUS | Marlo Surgical Technology | 1991-05-13 | 69 | 0 |
| K910577 | EDWARDS-WALLACE BOURNE HALL CATHETER | Marlo Surgical Technology | 1991-05-09 | 87 | 0 |
| K910578 | MCLAUGHLIN LAPAROSCOPIC GRASPER | Marlo Surgical Technology | 1991-04-03 | 51 | 0 |
| K910713 | FLYNN TISSUE PROBE AND BLUNT DISSECTOR | Marlo Surgical Technology | 1991-03-21 | 29 | 0 |
| K905759 | HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS | Marlo Surgical Technology | 1991-03-06 | 69 | 0 |
| K910287 | OTT CERVICAL TENACULUM | Marlo Surgical Technology | 1991-02-28 | 37 | 0 |
| K910579 | OVARIAN ASPIRATION/IRRIGATION NEEDLE | Marlo Surgical Technology | 1991-02-28 | 17 | 0 |
| K903078 | HASSON STABILIZING ACCESS CANNULA | Marlo Surgical Technology | 1990-12-17 | 158 | 0 |
| K903560 | CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS | Marlo Surgical Technology | 1990-11-06 | 90 | 0 |
| K903649 | BRADLEY TENACULUM HOLDER | Marlo Surgical Technology | 1990-11-02 | 81 | 0 |
| K894591 | GYNEGUIDE | Marlo Surgical Technology | 1989-10-10 | 78 | 0 |
| K894592 | LAMANO DIRECTORS | Marlo Surgical Technology | 1989-09-08 | 46 | 0 |
| K883839 | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | Marlo Surgical Technology | 1988-12-09 | 88 | 0 |
| K853061 | MST MODEL #ARLG-5 | Marlo Surgical Technology | 1985-09-04 | 47 | 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