FDA.reportPublic FDA data

HENSLER SURGICAL PRODUCTS, LLC

Matched from indexed company URL: Hensler Surgical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096579223009657922HENSLER SURGICAL PRODUCTS, LLC1Y2026-01-017038 Market Street STE 200 Wilmington NC US 28411

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00853755004232Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 8"" length, 1.0 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004249Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 8"" length, 1.5 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004256Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 9"" length, 0.5 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004263Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 9"" length, 1.0 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004270Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 9"" length, 1.5 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004287Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 10"" length, 0.5 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004294Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 10"" length, 1.0 mm tip, STERILE"910-399-7380tj@henslersurgical.com
00853755004300Hensler Surgical Disposable Non-Stick Bipolar - "Bayoneted bipolar forcep, Non-stick, single-use, yellow, 10"" length, 1.5 mm tip, STERILE"910-399-7380tj@henslersurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1422901444886169K101080NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXXGEI2010-06-21
1422901950724269

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI12010-06-21

GUDID#

Hensler Bone Press - The Bone Press is a medical device and has been developed to maximize the collection and separation of autologous bone from blood and irrigants for bone fusion applications. No additional accessories are provided with this device outside of what is in the kit.The Hensler Bone Press (HBP) is intended for sterile, single-use with a surgical suction line to collect autologous bone or tissue particles that are utilized in bone fusion. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians.

Hensler Surgical

2019-11-01

Hensler Bone Collector - The Hensler Bone Collector device is a brush/bristle cap with a screw on container. The bristles can sweep bone fragments from surgical tools into the container for use in augmentation procedures as a natural unadulterated bone filling material. The device is non-powered, single-use and disposable. The Hensler Bone Collector device is intended for sterile, single-use to manually collect autogeneous bone particles that are utilized in augmentation procedures. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians.

Hensler Surgical

2019-11-01