Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001297506

FEI Number

3001297506

Entity Name

DARLEYS SURGICAL CO.

City/State/Country

SIALKOT, PUNJAB, PK

Establishment Address

2-A KUTCHERY RD., SIALKOT, PUNJAB 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DARLEYS SURGICAL CO. (Owner Number: 9034166)

Owner / Operator Contact Address

2-A KUTCHERY RD., --, SIALKOT, PUNJAB, PK-NOTA 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARTICULATORS FILE, BONE, SURGICAL HOOK, SURGICAL, GENERAL & PLASTIC SURGERY Probes GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY TAPE, MEASURING, RULERS AND CALIPERS INSTRUMENT, FILLING, PLASTIC, DENTAL MIRROR, MOUTH TUBE, TONSIL SUCTION SCALER, PERIODONTIC CHISEL, BONE, SURGICAL HANDLE, SCALPEL CUTTER, SURGICAL TRAY, SURGICAL, INSTRUMENT RETRACTOR, ALL TYPES INSTRUMENT, MANUAL, SURGICAL, GENERAL USE CALIPER FORK, TUNING PLIERS, SURGICAL CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENTS, DENTAL HAND HOLDER, NEEDLE, GASTROENTEROLOGIC RETRACTOR, ALL TYPES HAMMER, SURGICAL CARVER, WAX, DENTAL CARVER, DENTAL AMALGAM, OPERATIVE CLAMP TRAY, IMPRESSION, PREFORMED SPECULUM, VAGINAL, METAL EXCAVATOR, DENTAL, OPERATIVE SCISSORS, ORTHOPEDIC, SURGICAL HAND, EXTERNAL LIMB COMPONENT, MECHANICAL ELEVATOR, SURGICAL, DENTAL KNIFE, SURGICAL SYRINGE, ENT RONGEURS BRACE, DRILL GAG, MOUTH CURETTE DILATOR, CERVICAL, FIXED SIZE FORCEPS SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJP	Articulators	Dental	Class 1	872.3150	2003-10-29
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2003-10-29
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2003-10-29
HXB	Probe	Orthopedic	Class 1	888.4540	2003-10-31
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2003-10-29
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-03-09
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2003-10-29
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2003-10-29
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2010-01-28
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2003-10-29
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2003-10-29
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2003-10-29
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-06-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2003-10-29
EIG	Retractor, All Types	Dental	Class 1	872.4565	2003-10-29
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-06-15
KTZ	Caliper	Orthopedic	Class 1	888.4150	2003-10-29
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2011-08-29
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-10-29
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-06-01
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2003-10-29
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2003-10-29
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2010-01-28
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-10-29
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2003-10-29
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2003-10-29
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2016-04-08
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2003-10-29
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2003-10-29
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2003-10-30
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2003-10-29
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2011-01-13
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2003-10-29
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-10-29
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2003-10-29
HTX	Rongeur	Orthopedic	Class 1	888.4540	2003-10-29
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2009-06-01
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2003-10-29
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2003-10-29
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2010-01-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-10-29
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2003-10-29

Official Correspondent

No official correspondent registered.

US Agent Details

MUHAMMAD QASIM Business: NADIR & CO LLC Email: nadirandcollc@gmail.com Phone: (760) 2845154

Related Public Records

Same Entity

DARLEYS SURGICAL CO.

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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

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2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3011511773	Candulor Dental GmbH	Rielasingen-Worblingen Baden-Wurttemberg, DE
1043617	WHIP-MIX CORP.	LOUISVILLE, KY, US
3009496224	IVOCLAR VIVADENT, INC.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001297506. Last updated year: 2026. Please use registration number 3001297506 when referencing this establishment in official correspondence.