Data / Medical devices / United States / Ethicon LLC
Ethicon LLC: FDA-registered device maker in Manati, PR, United States, 2 510(k) clearances
Ethicon LLC is registered with the FDA (registration 3032543753) in Manati, PR, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 6, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032543753
- Address
- PR-2, Km 45.6, Manati, PR, United States, 00674
- Owner or operator
- ETHICON INC. (2210968)
- Roles
- Manufacturer
- First device listed
- March 26, 2008
- Registered through
- 2026
- Brand names listed
- ETHIBOND, ETHIBOND EXCEL, ETHILON Nylon Suture, MERSILENE, MERSUTURE, NUROLON, PERMA-HAND/Mersilk Suture/Silk Suture, PROLENE Polypropylene Nonabsorbable Suture, SURGICAL GUT SUTURE (Plain and Chromic)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Absorbable, Natural | GAL | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Silk
- All makers of Suture, Absorbable, Natural
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated December 6, 2013. 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.