Tecnol New Jersey Wound Care, Inc.: FDA clearances and approvals
Tecnol New Jersey Wound Care, Inc. has 35 FDA 510(k) clearances (first 1976, latest 1991), across 23 product codes in 7 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 11 | 11 |
| FMQ | Restraint, Protective | 2 | 2 |
| FXP | Cover, Shoe, Operating-Room | 2 | 2 |
| BSS | Tube, Nasogastric | 1 | 1 |
| BWN | Table And Attachments, Operating-Room | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| EYR | Tourniquet, Gastro-Urology | 1 | 1 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | 1 | 1 |
| FMP | Protector, Skin Pressure | 1 | 1 |
| FOB | Bedpan | 1 | 1 |
Plus 13 more product codes.
Review panels
- General Hospital (19)
- General and Plastic Surgery (7)
- Gastroenterology and Urology (3)
- Physical Medicine (2)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Tecnol New Jersey Wound Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | FXX | 1991-08-23 | 64 |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | FXX | 1991-07-12 | 74 |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | FXX | 1991-07-08 | 69 |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | FXX | 1990-02-27 | 125 |
| K894205 | TECNOL SILK STRIP | FPX | 1989-07-25 | 36 |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | FXP | 1989-06-23 | 36 |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | BSS | 1989-05-30 | 85 |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | EYZ | 1989-05-23 | 78 |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | NAD | 1989-01-17 | 88 |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | KQZ | 1988-07-27 | 30 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tecnol New Jersey Wound Care, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Tecnol New Jersey Wound Care, Inc. have?
Tecnol New Jersey Wound Care, Inc. has 35 FDA 510(k) clearances (first 1976, latest 1991), across 23 product codes in 7 review panels.
How long does FDA take to clear Tecnol New Jersey Wound Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tecnol New Jersey Wound Care, Inc.'s cleared 510(k)s is 36 days.
What devices does Tecnol New Jersey Wound Care, Inc. make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 11); FMQ (Restraint, Protective, 2); FXP (Cover, Shoe, Operating-Room, 2).
Has Tecnol New Jersey Wound Care, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tecnol New Jersey Wound Care, Inc. Related entities may recall under other names.
Next steps
- See all 35 Tecnol New Jersey Wound Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Tecnol New Jersey Wound Care, Inc.'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.