Lukens Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 8
What Lukens Medical Corp. makes
Lukens Medical Corp. manufactures a range of surgical sutures, including nonabsorbable materials like polypropylene monofilament and braided polyester, as well as absorbable options such as PGA (polyglycolic acid) and surgical gut. Their portfolio also includes stainless steel and nylon sutures, designed for various tissue closure applications in surgical procedures. The company produces both coated and braided sutures, with specific formulations tailored for different medical uses.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered with the FDA’s 510(k) clearance system. Lukens Medical Corp. is based in the United States.
Catalogue
Lukens Silk Surgical Suture Ref K930942
Regimes: 510(k) Registry: 510(k)Lukens Polypropylene Monofilament Nonabsorbable Ref K930941
Regimes: 510(k) Registry: 510(k)Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture, Coated, Braided-U.S.P. Ref K965162
Regimes: 510(k) Registry: 510(k)Lukens Surgical Gut Suture Ref K930944
Regimes: 510(k) Registry: 510(k)Lukens Stainless Steel Surgical Suture Ref K930940
Regimes: 510(k) Registry: 510(k)Lukens Nylon Surgical Suture Ref K930943
Regimes: 510(k) Registry: 510(k)Braided Polyester Surgical Suture Ref K930945
Regimes: 510(k) Registry: 510(k)Lu-Tex Ii Ref K904535
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lukens Medical Corp. have in the registry?
The registry currently lists 8 devices for Lukens Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lukens Medical Corp.'s devices?
Among its 8 most recently registered devices, Lukens Medical Corp. has devices listed in FDA 510(k) (8 devices).
What risk classes do Lukens Medical Corp.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Lukens Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lukens Medical Corp. in the registry?
The most recently registered devices listed for Lukens Medical Corp. include LUKENS SILK SURGICAL SUTURE, LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE, LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE, COATED, BRAIDED-U.S.P. and LUKENS SURGICAL GUT SUTURE.