Entrigue Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Entrigue Surgical, Inc. makes
Entrigue Surgical, Inc. manufactures absorbable sutures, such as the BIOELAST 5-0 SUTURE (Model 500100), and surgical instruments for sinus and nasal procedures, including the SINUS DILATION SYSTEM and the MEDIENT MIDDLE TURBINATE IMPLANT. The company also produces the ENTACT SEPTAL STAPLER (Model 610-00100) for septoplasty applications.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Bioelast 5-0 Suture, Model 500100 Ref K072470
Regimes: 510(k) Registry: 510(k)Sinus Dilation System Ref K121351
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Entact Septal Stapler, Model 610-00100 Ref K082750
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entrigue Surgical, Inc. have in the registry?
The registry currently lists 4 devices for Entrigue Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entrigue Surgical, Inc.'s devices?
Among its 4 most recently registered devices, Entrigue Surgical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Entrigue Surgical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Entrigue Surgical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entrigue Surgical, Inc. in the registry?
The most recently registered devices listed for Entrigue Surgical, Inc. include BIOELAST 5-0 SUTURE, MODEL 500100, SINUS DILATION SYSTEM, MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) and ENTACT SEPTAL STAPLER, MODEL 610-00100.