Exmoor Plastics , Ltd.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Exmoor Plastics , Ltd.” (first 1981, latest 2010), across 18 product codes in 5 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | 16 | 16 |
| LRC | Instrument, Ent Manual Surgical | 5 | 5 |
| EPP | Splint, Nasal | 4 | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 2 | 2 |
| ETB | Prosthesis, Partial Ossicular Replacement | 2 | 2 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 2 | 2 |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 1 | 1 |
| EWL | Prosthesis, Laryngeal (Taub) | 1 | 1 |
Plus 8 more product codes.
Review panels
- Ear, Nose and Throat (37)
- General Hospital (2)
- Anesthesiology (1)
- General and Plastic Surgery (1)
- Clinical Toxicology (1)
Most recent Exmoor Plastics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093863 | EPIDRUM | FMF | 2010-05-10 | 144 |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | LRC | 1999-03-05 | 28 |
| K980828 | EXMOOR MYRINGOTOMY KIT | ETD | 1998-10-22 | 233 |
| K981143 | DILKES LASER/SUCTION CANNULAE | GEX | 1998-09-14 | 168 |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) | KHJ | 1998-07-16 | 393 |
| K981088 | MILLS COLUMELLA PROSTHESIS | ETA | 1998-06-05 | 72 |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | ETB | 1998-05-20 | 61 |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | ETD | 1998-05-13 | 208 |
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | ESZ | 1998-01-27 | 78 |
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | JZF | 1998-01-23 | 123 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Exmoor Plastics , Ltd..
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 Exmoor Plastics , Ltd.?
FDA lists 43 510(k) clearances under the applicant name “Exmoor Plastics , Ltd.” (first 1981, latest 2010), across 18 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 Exmoor Plastics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exmoor Plastics , Ltd. is 78 days.
Which FDA product codes appear under Exmoor Plastics , Ltd.?
The most frequent FDA product codes under this applicant name are ETD (Tube, Tympanostomy, 16); LRC (Instrument, Ent Manual Surgical, 5); EPP (Splint, Nasal, 4).
Next steps
- See all 43 Exmoor Plastics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ETD, Exmoor Plastics , Ltd.'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.