Conceptus, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Conceptus, Inc.” (first 1994, latest 1998), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 214 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 |
| MKO | Falloposcope | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 | 1 |
| MOV | Catheters, Salpingography | 1 | 1 |
Review panels
Most recent Conceptus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974028 | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | MKO | 1998-01-21 | 90 |
| K972210 | RESECTOSCOPE SAFETY SHEATH | HIH | 1997-09-05 | 86 |
| K962587 | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | MKO | 1997-01-31 | 214 |
| K954164 | HYSTEROSCOPE | HIH | 1996-03-12 | 189 |
| K953314 | CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM | MOV | 1995-07-28 | 16 |
| K932387 | CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL | HET | 1995-03-06 | 658 |
| K932993 | INTRAUTERINE CATHETER AND INTRODUCER | MFD | 1995-01-06 | 567 |
| K933981 | CERVICAL CATHETER | LKF | 1994-12-27 | 498 |
| K933723 | CONCEPTUS UTERINE CATHETER | LKF | 1994-12-27 | 512 |
Recalls
openFDA lists no recalls under a recalling firm named Conceptus, Inc..
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 Conceptus, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Conceptus, Inc.” (first 1994, latest 1998), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Conceptus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Conceptus, Inc. is 214 days.
Which FDA product codes appear under Conceptus, Inc.?
The most frequent FDA product codes under this applicant name are HIH (Hysteroscope (And Accessories), 2); LKF (Cannula, Manipulator/Injector, Uterine, 2); MKO (Falloposcope, 2).
Next steps
- See all 9 Conceptus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIH, Conceptus, Inc.'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.