Annex Medical, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Annex Medical, Inc.” (first 1989, latest 1995), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 10 | 10 |
| FGO | Dislodger, Stone, Flexible | 4 | 4 |
| DWZ | Device, Biopsy, Endomyocardial | 2 | 2 |
| FDX | Endoscopic Cytology Brush | 2 | 2 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
Review panels
Most recent Annex Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | FFL | 1995-10-26 | 37 |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | FCL | 1995-07-19 | 27 |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | FFL | 1995-07-19 | 107 |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | FFL | 1995-05-11 | 24 |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | FFL | 1994-02-25 | 151 |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | FFL | 1994-01-07 | 101 |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | FGO | 1994-01-07 | 105 |
| K925267 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | GCJ | 1993-02-10 | 114 |
| K925559 | BILIARY STONE DISLODGER | LQR | 1992-12-17 | 44 |
| K921401 | BIOPSY FORCEPS | DWZ | 1992-10-21 | 211 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Annex 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 Annex Medical, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Annex Medical, Inc.” (first 1989, latest 1995), across 9 product codes in 3 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 Annex Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Annex Medical, Inc. is 76 days.
Which FDA product codes appear under Annex Medical, Inc.?
The most frequent FDA product codes under this applicant name are FFL (Dislodger, Stone, Basket, Ureteral, Metal, 10); FGO (Dislodger, Stone, Flexible, 4); DWZ (Device, Biopsy, Endomyocardial, 2).
Next steps
- See all 23 Annex Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FFL, Annex 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.