Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008439467

FEI Number

3008439467

Entity Name

PURPLE SURGICAL INTERNATIONAL LIMITED

City/State/Country

Herts England, GB

Establishment Address

2 Chestnut House, Farm Close, Shenley, Herts England WD7 9AD, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Purple Surgical International Limited (Owner Number: 10033672)

Owner / Operator Contact Address

2 Chestnut House, Farm Close, Shenley, Herts, GB-ENG WD7 9AD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endo Retrieval Pouches - Various names and models PS3400, PS3401 Tissue Retrieval Pouches - Various names and models PS6100 5mm Laparoscopic Electrodes Monopolar Cables Laparoscopic Blunt Tip Disector 5 x 41cm Single Use PS3885, PS3886 Various names and models Camera Sleeve - Various names and models PS3900 PS6204 Curette Flexible 4 mm PS6205 Curette Flexible, 5 mm PS6206 Curette Flexible 6 mm, PS6207 Curette Flexible 7 mm PS6208 Curette Flexible 8 mm, PS6210 Curette Flexible 10 mm, PS6212 Curette Flexible 12 mm PS6010 Curette, Rigid, Straight 10 mm, PS6011 Curette, Rigid, Straight 11 mm, PS6012 Curette, Rigid, Straight 12 mm PS6007 Curette, Rigid, Straight 7 mm, PS6008 Curette, Rigid, Straight 8 mm, PS6009 Curette, Rigid, Straight 9 mm PS6107 Curette, Rigid, Curved 7 mm, PS6108 Curette, Rigid, Curved 8 mm, PS6109 Curette, Rigid, Curved 9 mm PS6110 Curette, Rigid, Curved 10 mm, PS6111 Curette, Rigid, Curved 11 mm, PS6112 Curette, Rigid, Curved 12 mm Model Number: PS3852ULT & Laparascopic Accessories Purple Surgical International Ltd Disposable Trocar PS3871 Irrigation Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2010-12-01
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2016-11-08
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-12-04
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-12-01
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2010-12-01
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-01-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-09-13
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2010-09-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-09-13
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2012-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Purple Surgical International Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008571754	Purple Surgical Manufacturing Limited	Taunton Somerset, GB

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008439467. Last updated year: 2026. Please use registration number 3008439467 when referencing this establishment in official correspondence.