FDA.reportPublic FDA data

DuraStat

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154896993015489699DuraStat1N2026-01-011101 E 6th St Unit B Austin TX US 78702

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
00850061177001DuraStat - DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.18008048018CUSTOMERSERVICE@DURASTAT.COM
00850061177018DuraStat - 10-CT CASE: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.18008048018CUSTOMERSERVICE@DURASTAT.COM
00850061177032DuraStat - 10-CT INNER PACK: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.18008048018CUSTOMERSERVICE@DURASTAT.COM
00850061177049TissueStat - 10-CT CASE: TissueStat delivery devices are indicated to aid in suturing as determined by a licensed physician familiar with the possible side effects, typical findings, limitation, indications, and contra-indications of performing such procedures. This device must be loaded with a double-armed 0 PGLA suture attached to 12mm straight needles. The knot pusher is intended to facilitate secure seating of the suture knot.18008048018CUSTOMERSERVICE@DURASTAT.COM
00850061177056TissueStat - TissueStat delivery devices are indicated to aid in suturing as determined by a licensed physician familiar with the possible side effects, typical findings, limitation, indications,and contra-indications of performing such procedures. The device must be loaded with a double-armed 0 PGLA suture attached to 12mm straight needles. The knot pusher is intended to facilitate secure seating of the suture knot.18008048018CUSTOMERSERVICE@DURASTAT.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2254091544069298K173335Gazelle PTFE and Suture Delivery DeviceNBY2018-02-08
2254091921324299K043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLESGAM2005-04-06
2254091024067325

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBY22018-02-08
GAM12005-04-06

GUDID#

DuraStat - DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.

Durastat LLC

2026-03-04

DuraStat - 10-CT INNER PACK: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.

Durastat LLC

2026-03-04

DuraStat - 10-CT CASE: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.

Durastat LLC

2026-03-04

DuraStat - DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.

Durastat LLC

2026-03-04