Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008280196

FEI Number

3008280196

Entity Name

DTR MEDICAL LTD

City/State/Country

Swansea, GB

Establishment Address

17 Clarion Court, clarion Court Enterprise Park, Swansea SA6 8RF, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DTR Medical Ltd (Owner Number: 10083093)

Owner / Operator Contact Address

17 Clarion Court, Swansea, GB-SWA SA6 8RF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gillies Skin Hook Episiotomy Scissors Oral Rotating Biopsy Punch Mosquito Forceps Spencer Wells Artery Forceps Baby Overholt Artery Forceps Crile Artery Forceps Kocher Ochsner Artery Forceps Kocher Artery Forceps Silicone Tube House Curette MacDonald Dissector Schuknecht Pick Tubing Clamps Iris Scissors Vannas Scissors Beckmann Adenoid Curette Lambert Tarsal Cyst Forceps Birmingham Tarsal Cyst Forceps Chalazion Curette Silicone Tubing Phaco Chopper Sinskey Hook Hartmann Nasal Speculum Thudichum Nasal Specula Punctum Seeker Lacrimal Probe Trousseau Tracheal Dilator Thudichum Nasal Specula Hartmann Nasal Speculum Oval Ear Specula Tumarkin Ear Specula Shea Ear Specula Rosen Round Ear Specula Belucci Sinus Suction Handle Bronchoscopy Suction Handle Zoellner Suction Handle Zoellner Fine Ends Endoscopic Suction Tube Magill Suction Handle Oesophageal Suction Handle Barron Suction Handle Brackmann Schuknecht Suction Handle Micro Laryngeal Suction Handle Clearway Suction Handle Tapered Suction Jobson Horne Probe Grooved Director Silicone Bands Silicone Slings Fish Hook Retractors Maxillofacial Retractors College Dental Forceps Phlebectomy Hook Clamp Covers Tongue Depressors Negus Aspirating Dissector Freer Aspirating Hockey Stick Dissector Dental Syringes Zoellner Type Frazier Suction Handles Tapered Suction Handle Frazier Lampert Type Micro Suction (Verhoven) Fine Ends Brackmann Suction Handle House Suction and Irrigation Handle Oesophageal / Laryngeal with suction control F.E.S.S Sinus Suction Tube Aspiration Cannula Yankauer Suction Handle Suction Handles Cawthorne Hook Formby Cerumen Hook & Probe Cawthorne Straight Point Straight Tying Forceps Debakey Needle Holder Kilner Needle Holder Halsey Needle Holder Birks Tying Forceps Mayo Hegar Needle Holder Crilewood Needle Holder Suction Regulator Cervical Biopsy Punch Kratz-Barraquer Eye Speculum Keele Mucosectomy Forceps Clamp Covers St. Martins Forceps Moorfield Forceps Epilation Forceps McIndoe Dissecting Forceps Fine Suture Forceps Fine Tip Adson Forceps Allis Tissue Forceps Adson Forceps Rampley Sponge Holders Gillies Toothed Dissecting Forceps Magill Catheter Forceps DeBakey Atraumatic Dissecting Forceps Kerrison Rongeur Punch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-01-03
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2025-06-24
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2023-10-28
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2025-01-03
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2025-01-03
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-01-03
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-01-03
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-01-03
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-02-04
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-06-24
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-01-03
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-06-24
KAG	Holder, Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2025-01-03
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2025-06-24
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2025-06-24
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2026-06-16
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-01-03
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2025-01-03
GAJ	Stripper, Vein, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-06-24
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-01-03
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2025-01-03
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-08-10
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-08-10
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2024-02-05
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2023-08-10
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2025-01-03
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2025-01-03
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2021-10-25
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-06-16
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-08-10
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-01-03

Official Correspondent

Natasha Brown

US Agent Details

Carol Buchert Business: Summit Medical LLC Email: rasummit@innoviamedical.com Phone: (612) 7893966

Related Public Records

Same Entity

DTR Medical Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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9681161	REBSTOCK INSTRUMENTS GMBH	DUERBHEIM Baden-Wurttemberg, DE
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008280196. Last updated year: 2026. Please use registration number 3008280196 when referencing this establishment in official correspondence.