Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004361445

FEI Number

3004361445

Entity Name

AMERICAN MEDICAL ENDOSCOPY

City/State/Country

Doral, FL, US

Establishment Address

3020 NW 82ND AVE., Doral, FL 33122, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

American Medical Endoscopy (Owner Number: 9059843)

Owner / Operator Contact Address

3020 NW 82ND AVE., --, Doral, FL 33122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060233

PMA Number

N/A

All Registered Proprietary Names

Strauss Surgical Strauss Surgical AME-4IN1-VIDN-SET Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Cystoscopes & Hysteroscopes Strauss Surgical Strauss Surgical cystoscope, hysteroscope and accessories Instruments Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical Strauss Surgical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-04-13
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-04-13
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2022-04-13
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-04-13
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-04-13
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-08-02
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2023-11-28
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2022-09-21
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2022-04-13
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-12-31
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-12-31
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-12-31
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-05-01
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-12-31
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2024-11-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-08-23
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2022-09-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-22
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2022-09-21
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2022-04-13
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-09-21
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-08-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-04-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2026-04-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-10-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-04-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2026-04-10
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	Class 2	876.4500	2023-08-25
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2022-04-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-10-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-10-29
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-10-29
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2019-12-16
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2022-09-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-10-11

Official Correspondent

Matthew Schwimmer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Medical Endoscopy

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
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K961841	C.R. Bard, Inc.	BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)	1996-10-09
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004361445. Last updated year: 2026. Please use registration number 3004361445 when referencing this establishment in official correspondence.