Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1315756

FEI Number

1315756

Entity Name

Weco Manufacturing Group-Henrietta

City/State/Country

Rochester, NY, US

Establishment Address

275 COMMERCE DR, Rochester, NY 14623, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

DJ Acquisition FTT, LLC (Owner Number: 1315756)

Owner / Operator Contact Address

275 Commerce Drive, --, Rochester, NY 14623, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2007-04-23
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2008-03-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-04-23
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2016-09-21
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1978-03-31
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2007-04-23
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2007-04-23
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	1978-03-31
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2009-04-29
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2007-04-23
FXF	Speculum, Illuminated	General, Plastic Surgery	Class 1	878.1800	1978-03-31
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2007-04-23
HDG	Speculum, Vaginal, Metal, Fiberoptic	Obstetrics/Gynecology	Class 1	884.4520	2007-04-23
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-03-31
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2007-04-23
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2007-04-23
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2019-07-08
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2007-04-23
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2007-04-23
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	1978-03-31
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1978-03-31
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2007-04-23
GCF	Proctoscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-05
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-04-23
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2007-04-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-04-23
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2007-04-23
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2007-04-23
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2007-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DJ Acquisition FTT, LLC

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
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
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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3029082594	CHOOSE SURGICAL INSTRUMENTS	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1315756. Last updated year: 2026. Please use registration number 1315756 when referencing this establishment in official correspondence.