HAEMOBAND MULTI-LIGATOR
HAEMOBAND SURGICAL LTD.
HAEMOBAND SURGICAL LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007388124 | 3007388124 | HAEMOBAND SURGICAL LTD | 1 | N | 2026-01-01 | The Mount Conference Centre 2 Woodstock Link Belfast Northern Ireland GB BT6 8DD |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 111954 | 1954192832 | K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) | FER | 2025-10-09 |
| 111954 | 1778317524 | K091519 | HAEMOBAND MULTI-LIGATOR | FHN | 2009-07-28 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Haemoband-PLUS Band Ligator - Haemoband-PLUS Band Ligator is a class 2 latex free, single use, disposable instrument (medical device) used for the band ligation of internal 1st, 2nd, and 3rd degree hemorrhoids. The Haemoband-PLUS Band Ligator device must only be used by trained professionals. The Haemoband-PLUS Band Ligator is an automated multi-ligator applicator device, comprising a one-piece plastic gun with four main components• an insertion barrel or probe• a protector firing nozzle, pre-loaded with four bands; and• an innovative dual grip and firing mechanism• universal suction connectorThe device is to be attached to a standard suction supply via the universal connector on the handle. The trigger is then partially depressed to induce suction, then depressed fully to release the band onto the hemorrhoidal tissue secured. Grip from the trigger is then released with the next band automatically reloaded, ready for next band application.
2026-04-28
SleeveLUX 24 Anoscope/Proctoscope - The SleeveLUX 24 Proctoscope is a class 2, self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree haemorrhoids. The SleeveLUX 24 Proctoscope must only be used by trained professionals.
2026-04-28
SleeveLUX 16 Anoscope/Proctoscope - The SleeveLUX 16 Proctoscope is a class 2, self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids. The SleeveLUX 16 Proctoscope must only be used by trained professionals.
2026-04-28