Marlo Surgical Technology: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Marlo Surgical Technology” (first 1985, latest 1996), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 10 | 10 |
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| MFD | Cannula, Intrauterine Insemination | 2 | 2 |
| GCM | Endoscope, Rigid | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| GSJ | Antiserum, Fluorescent, Francisella Tularensis | 1 | 1 |
| HDC | Tenaculum, Uterine | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HIS | Condom | 1 | 1 |
Plus 4 more product codes.
Review panels
- Obstetrics and Gynecology (15)
- General and Plastic Surgery (8)
- Gastroenterology and Urology (2)
- General Hospital (1)
- Microbiology (1)
Most recent Marlo Surgical Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960810 | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM | HET | 1996-10-21 | 236 |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | MFD | 1996-07-31 | 48 |
| K924611 | IRRIGATION PUMP AND TUBING SET | HET | 1994-06-30 | 657 |
| K932832 | PRIMUS INSULATED FORCEPS | HET | 1994-02-25 | 261 |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | HET | 1994-02-25 | 268 |
| K920611 | MARLOW LAPAROSCOPIC GRASPING FORCEP | GCJ | 1993-04-20 | 434 |
| K914153 | OTT INSUFFLATOR FILTER PLUS/TUBING SET | HIF | 1992-04-02 | 199 |
| K914869 | MARLOW LAPAROSCOPIC SCISSORS | GCJ | 1992-01-15 | 78 |
| K913954 | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS | GCJ | 1991-12-18 | 104 |
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | GSJ | 1991-11-19 | 21 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Marlo Surgical Technology.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Marlo Surgical Technology?
FDA lists 28 510(k) clearances under the applicant name “Marlo Surgical Technology” (first 1985, latest 1996), across 14 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Marlo Surgical Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marlo Surgical Technology is 80 days.
Which FDA product codes appear under Marlo Surgical Technology?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 10); GCJ (Laparoscope, General & Plastic Surgery, 5); MFD (Cannula, Intrauterine Insemination, 2).
Next steps
- See all 28 Marlo Surgical Technology clearances with predicates and recalls
- Run predicate analysis for product code HET, Marlo Surgical Technology's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.