FDA.reportPublic FDA data

Signum Surgical USA, Inc.

Matched from indexed company URL: Signum Surgical Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30381936983038193698Signum Surgical USA, Inc.1Y2026-01-01175 Strafford Ave Ste One Wayne PA US 19087

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
05391546930001BioHealx Anal Fistula Device - The BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non branching fistulas in ano via tissue apposition.BH201X1 is a single unit of the BioHealx Anal Fistula Device. Each single unti contains a single absorbable implant preloaded into a single use delivery system. It is provided sterile and is intended for single use.BH201X1 can be provided as a single unit or as a multipack of 5 units in a box.6108606577carol@signumsurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3396111478568273DEN240007BioHealx Anal Fistula DeviceQML2024-07-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QML12024-07-01

GUDID#

BioHealx Anal Fistula Device - The BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non branching fistulas in ano via tissue apposition.BH201X1 is a single unit of the BioHealx Anal Fistula Device. Each single unti contains a single absorbable implant preloaded into a single use delivery system. It is provided sterile and is intended for single use.BH201X1 can be provided as a single unit or as a multipack of 5 units in a box.

SIGNUM SURGICAL LIMITED

2025-06-25