A & A Medical, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “A & A Medical, Inc.” (first 1988, latest 2001), across 17 product codes in 4 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HHM | Sound, Uterine | 2 | 2 |
| HHT | Spatula, Cervical, Cytological | 2 | 2 |
| MFD | Cannula, Intrauterine Insemination | 2 | 2 |
| FMC | Patient Examination Glove | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 1 | 1 |
| HEE | Set, Anesthesia, Paracervical | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Plus 7 more product codes.
Review panels
- Obstetrics and Gynecology (17)
- General and Plastic Surgery (4)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent A & A Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013491 | HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 | LKF | 2001-11-19 | 28 |
| K013437 | SF SH CATHETER, MODEL R65-945 | LKF | 2001-11-19 | 33 |
| K003949 | TACKER, MODEL R65-933 | OCW | 2001-07-25 | 216 |
| K011512 | MMODIFICATION TO LAMINARIA | HDY | 2001-07-09 | 54 |
| K010510 | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 | HET | 2001-05-16 | 84 |
| K010789 | CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 | GCJ | 2001-04-27 | 43 |
| K010056 | UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 | LKF | 2001-02-01 | 24 |
| K000027 | INSUFFLATION NEEDLE, MODEL R65-933 | HIF | 2000-04-03 | 89 |
| K994256 | SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 | GCJ | 2000-02-03 | 48 |
| K974038 | THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT | JCX | 1998-05-11 | 199 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A & A Medical, 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 A & A Medical, Inc.?
FDA lists 23 510(k) clearances under the applicant name “A & A Medical, Inc.” (first 1988, latest 2001), across 17 product codes in 4 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 A & A Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A & A Medical, Inc. is 60 days.
Which FDA product codes appear under A & A Medical, Inc.?
The most frequent FDA product codes under this applicant name are LKF (Cannula, Manipulator/Injector, Uterine, 3); GCJ (Laparoscope, General & Plastic Surgery, 2); HHM (Sound, Uterine, 2).
Next steps
- See all 23 A & A Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKF, A & A Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.