Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614093

FEI Number

3002802903

Entity Name

STONE INSTRUMENTS CO.

City/State/Country

SIALKOT Punjab, PK

Establishment Address

10 KM DASKA ROAD, SIALKOT Punjab 51010, PK

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

STONE INSTRUMENTS CO. (Owner Number: 9040276)

Owner / Operator Contact Address

10 KM DASKA ROAD, --, Sialkot, PK-NOTA 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OTOSCOPE NSTRUMENT, MANUAL, SURGICAL, GENERAL USE DILATOR, TRACHEAL STETHOSCOPE, MANUAL CURETTE LARYNGOSCOPE, RIGID INSTRUMENT, BENDING OR CONTOURING FORCEPS ELEVATOR BRACE, DRILL HAMMER, SURGICAL SPECULUM, VAGINAL, METAL, FIBEROPTIC BENDER RONGEURS TAP, BONE FORCEPS, BIOPSY, GYNECOLOGICAL PLATE, BASE, SHELLAC Accessories, fixation, spinal intervertebral body TRAY, SURGICAL, INSTRUMENT SCREWDRIVER BIT, DRILL FORK, TUNING PLIER, ORTHODONTIC CRIMPER, PIN ELEVATOR, ENT BARS, PARALLEL, EXERCISE ACCESSORIES, RETRACTOR, DENTAL FORCEPS, WIRE HOLDING CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY RETRACTOR, ALL TYPES Guide, surgical, instrument CATHETERS, SUCTION, TRACHEOBRONCHIAL PUNCH, SURGICAL PROBE SCISSORS, GENERAL, SURGICAL INSTRUMENTS, SURGICAL, CARDIOVASCULAR CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY CALIPER AWL HOOK, SURGICAL, GENERAL & PLASTIC SURGERY Probes Orthopedic manual surgical instrument RETRACTOR PLIERS, SURGICAL RONGEUR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2000-02-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-07-29
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2012-05-26
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2022-06-20
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2012-05-26
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2024-01-17
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2023-03-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2000-02-01
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2024-01-17
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2020-06-10
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-02-01
HDG	Speculum, Vaginal, Metal, Fiberoptic	Obstetrics/Gynecology	Class 1	884.4520	2012-05-26
HXW	Bender	Orthopedic	Class 1	888.4540	2019-04-04
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-07-29
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2019-04-04
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2018-03-09
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2016-05-31
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	Class 1	888.4540	2023-02-21
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-07-29
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2008-03-12
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-06-10
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2000-02-01
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2025-05-14
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2020-06-10
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-01-01
IOE	Bars, Parallel, Exercise	Physical Medicine	Class 1	890.5370	2019-06-11
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2025-07-29
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2025-07-29
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-02-21
EIG	Retractor, All Types	Dental	Class 1	872.4565	2012-05-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-05-14
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2016-05-31
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-19
HXB	Probe	Orthopedic	Class 1	888.4540	2008-03-12
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-02-01
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2025-08-20
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-30
KTZ	Caliper	Orthopedic	Class 1	888.4150	2021-04-12
HWJ	Awl	Orthopedic	Class 1	888.4540	2008-03-12
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-05-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-03-12
HXB	Probe	Orthopedic	Class 1	888.4540	2015-04-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-08-20
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-03-09
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-12-31

Official Correspondent

ATHAR JAMIL

US Agent Details

Austin Cummings Business: VORZEIGEN Email: austin@vorzeigen.com Phone: (765) 8271500

Related Public Records

Same Entity

STONE INSTRUMENTS 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
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-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614093. Last updated year: 2026. Please use registration number 9614093 when referencing this establishment in official correspondence.