Wells Johnson Co.: FDA clearances and approvals
Wells Johnson Co. has 15 FDA 510(k) clearances (first 1983, latest 1999), across 14 product codes in 5 review panels. Median 510(k) review time: 73 days.
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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 | 1 |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| FWL | Camera, Cine, Endoscopic, Without Audio | 1 | 1 |
| FZW | Expander, Surgical, Skin Graft | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HJM | Transilluminator, Ac-Powered | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (7)
- General Hospital (4)
- Dental (1)
- Ear, Nose and Throat (1)
- Ophthalmic (1)
Most recent Wells Johnson Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991437 | WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 | FRN | 1999-08-30 | 126 |
| K984448 | BIRCOLL BALLOON DISSECTOR | FZW | 1999-01-28 | 45 |
| K971580 | UAS ULTRASONIC ASPIRATOR SYSTEM | LFL | 1997-12-09 | 223 |
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | EQH | 1995-12-04 | 368 |
| K945500 | WELLS JOHNSON FIXATION SYSTEM | JEY | 1995-09-21 | 316 |
| K951519 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | FWL | 1995-06-14 | 72 |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | HJM | 1995-03-02 | 91 |
| K945805 | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE | GEI | 1994-12-13 | 15 |
| K854068 | EXTERNAL MECHANICAL FASTENER | — | 1985-11-22 | 49 |
| K843188 | WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP | JOL | 1984-09-20 | 38 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wells Johnson Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Wells Johnson Co.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Wells Johnson Co. have?
Wells Johnson Co. has 15 FDA 510(k) clearances (first 1983, latest 1999), across 14 product codes in 5 review panels.
How long does FDA take to clear Wells Johnson Co.'s 510(k)s?
The median time from FDA receipt to decision across Wells Johnson Co.'s cleared 510(k)s is 73 days.
What devices does Wells Johnson Co. make?
Its most frequent FDA product codes are GEA (Cannula, Surgical, General & Plastic Surgery, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), 1).
Has Wells Johnson Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Wells Johnson Co. Related entities may recall under other names.
Next steps
- See all 15 Wells Johnson Co. clearances with predicates and recalls
- Run predicate analysis for product code GEA, Wells Johnson Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.