Data / Medical devices / United States / Professional Surgical Instruments Co., Inc./Psi
Professional Surgical Instruments Co., Inc./Psi: FDA-registered device maker in E Brunswick, NJ, United States, 1 510(k) clearance
Professional Surgical Instruments Co., Inc./Psi is registered with the FDA (registration 2433825) in E Brunswick, NJ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2433825
- FEI number
- 1000121617
- Address
- 153 Main ST., E Brunswick, NJ, United States, 08816
- Owner or operator
- PROFESSIONAL SURGICAL INSTRUMENTS CO., INC. (2433825)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 25, 2016
- Registered through
- 2027
- Brand names listed
- 150 Universal Extraction Forceps, Serrated, 151 Universal Extraction Forceps, Serrated, 222 Extraction Forceps, 23 Cowhorn Extraction Forceps, 4.5" Straight Iris Scissors, Satin With Tip Protector, 46L English Pattern Extraction Forceps, 74N English Pattern Extraction Forceps, 88L Extraction Forceps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Specification developer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 1, 2018 | K172500 | Technoweb Surgical Mask | FXX | Substantially Equivalent | Yts Global, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Plier, Orthodontic
- All makers of Wire, Orthodontic
- All makers of Mask, Surgical
- All makers of Scissors, General, Surgical
Updated March 1, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.