Marlo Surgical Technology
Willoughby, OH, US
Marlo Surgical Technology appears in FDA device records in Willoughby, OH. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Marlo Surgical Technology between 1985 and 1996. The busiest year on record is 1991, with 13. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 3 |
| 1991 | 13 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 3 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960810 | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM | HET | Substantially Equivalent | |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | MFD | Substantially Equivalent | |
| K924611 | IRRIGATION PUMP AND TUBING SET | HET | Substantially Equivalent | |
| K932832 | PRIMUS INSULATED FORCEPS | HET | Substantially Equivalent | |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | HET | Substantially Equivalent | |
| K920611 | MARLOW LAPAROSCOPIC GRASPING FORCEP | GCJ | Substantially Equivalent | |
| K914153 | OTT INSUFFLATOR FILTER PLUS/TUBING SET | HIF | Substantially Equivalent | |
| K914869 | MARLOW LAPAROSCOPIC SCISSORS | GCJ | Substantially Equivalent | |
| K913954 | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS | GCJ | Substantially Equivalent | |
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | GSJ | Substantially Equivalent | |
| K913964 | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | HTD | Substantially Equivalent | |
| K913586 | MARLOW VERRES NEEDLES | GCT | Substantially Equivalent | |
| K911164 | REICH SUCTION/IRRIGATION CANNULA | GCJ | Substantially Equivalent | |
| K911149 | PAL (PROBE FOR ASPIRATION AND LAVAGE) | GCJ | Substantially Equivalent | |
| K910907 | PUMP VAC PLUS | HET | Substantially Equivalent | |
| K910577 | EDWARDS-WALLACE BOURNE HALL CATHETER | MFD | Substantially Equivalent | |
| K910578 | MCLAUGHLIN LAPAROSCOPIC GRASPER | HIS | Substantially Equivalent | |
| K910713 | FLYNN TISSUE PROBE AND BLUNT DISSECTOR | HET | Substantially Equivalent | |
| K905759 | HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS | HET | Substantially Equivalent | |
| K910579 | OVARIAN ASPIRATION/IRRIGATION NEEDLE | HET | Substantially Equivalent | |
| K910287 | OTT CERVICAL TENACULUM | HDC | Substantially Equivalent | |
| K903078 | HASSON STABILIZING ACCESS CANNULA | HET | Substantially Equivalent | |
| K903560 | CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS | HET | Substantially Equivalent | |
| K903649 | BRADLEY TENACULUM HOLDER | KDC | Substantially Equivalent | |
| K894591 | GYNEGUIDE | GEX | Substantially Equivalent | |
| K894592 | LAMANO DIRECTORS | GCM | Substantially Equivalent | |
| K883839 | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | KYP | Substantially Equivalent | |
| K853061 | MST MODEL #ARLG-5 | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GSJAntiserum, Fluorescent, Francisella Tularensis
- MFDCannula, Intrauterine Insemination
- HISCondom
- GCMEndoscope, Rigid
- HTDForceps
- KDCInstrument, Surgical, Disposable
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- GCTLight Source, Endoscope, Xenon Arc
- GEXPowered Laser Surgical Instrument
- KYPSnake Bite Suction Kit
- HDCTenaculum, Uterine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain