Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008828237

FEI Number

3008828237

Entity Name

WALCOTT RX PRODUCTS, INC.

City/State/Country

Ocean View, NJ, US

Establishment Address

3 Harrys Court, Suite D, Ocean View, NJ 08230, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Walcott Rx Products, Inc. (Owner Number: 10085083)

Owner / Operator Contact Address

3 Harrys Court, Suite D, Ocean View, NJ 08230, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc Walcott Rx Products, Inc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2022-07-27
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-05-18
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-07
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2022-07-08
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2024-01-22
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-27
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2022-07-25
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-08-10
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2024-01-22
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-07-25
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-05-04
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2022-07-25
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2022-07-27

Official Correspondent

Brandon Walcott

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Walcott Rx Products, Inc.

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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
3039414397	JAY-MED	SIALKOT Punjab, PK
3005440795	XINHUA SURGICAL INSTRUMENT CO. LTD.	ZIBO Shandong, CN
9611390	FRIEDRICH DANIELS GMBH	SOLINGEN North Rhine-Westphalia, DE
3007695959	Boston Scientific Corporation	El Coyol Alajuela, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008828237. Last updated year: 2026. Please use registration number 3008828237 when referencing this establishment in official correspondence.