NEPTUNE MEDICAL, INC

Matched from indexed company URL: Neptune Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3015451828	3015451828	NEPTUNE MEDICAL, INC	1	N	2026-01-01	1828 El Camino Real 5th Floor Burlingame CA US 94010

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850006222025	Pathfinder® Endoscope Overtube with Balloon - GI 110140B-1	8882028401	info@neptunemedical.com
00850006222032	Pathfinder® Endoscope Cap - GI EC-0412-1	888-202-8401	info@neptunemedical.com

neptunemedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
233970	1376021087	K240853	Pathfinder® CR System	FED	2024-06-27
233970	1454926934	K230801	Pathfinder Endoscope Overtube with Balloon Device	FED	2023-07-28
233970	1646118306	K211301	Pathfinder Endoscope Overtube	FED	2021-05-28
233970	2036278495	K210915	Pathfinder Endoscope Cap	FDS	2021-05-25
233970	1704707177	K191415	Pathfinder Endoscope Overtube	FED	2019-08-30
233970	1491952253

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FED	4	2024-06-27
FDS	1	2021-05-25

PMN#

Pathfinder® CR System
2024-06-27
Neptune Medical, Inc.
Pathfinder Endoscope Overtube with Balloon Device
2023-07-28
Neptune Medical, Inc.
Pathfinder Endoscope Overtube
2021-05-28
Neptune Medical, Inc.
Pathfinder Endoscope Cap
2021-05-25
Neptune Medical, Inc.
Pathfinder Endoscope Overtube
2019-08-30
Neptune Medical, Inc.

GUDID#

Pathfinder® Endoscope Cap - GI EC-0412-1
NEPTUNE MEDICAL INC.
2021-06-02
Pathfinder® CR System - The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices.
NEPTUNE MEDICAL INC.
2024-07-09
Pathfinder® Endoscope Overtube with Balloon - GI 085140B-1
NEPTUNE MEDICAL INC.
2023-11-20
Pathfinder® Endoscope Overtube with Balloon - GI 110140B-1
NEPTUNE MEDICAL INC.
2023-11-20
Pathfinder® Endoscope Overtube - GI 145110-2
NEPTUNE MEDICAL INC.
2021-08-31
Pathfinder® Endoscope Overtube - GI 085110-2
NEPTUNE MEDICAL INC.
2021-08-31
Pathfinder® Endoscope Overtube - GI 065110-2
NEPTUNE MEDICAL INC.
2021-08-31
Pathfinder® Endoscope Overtube - GI 110160-2
NEPTUNE MEDICAL INC.
2021-06-07
Pathfinder® Endoscope Overtube - GI 085160-2
NEPTUNE MEDICAL INC.
2021-06-07
Pathfinder® Endoscope Overtube - GI 065160-2
NEPTUNE MEDICAL INC.
2021-06-07
Pathfinder® Endoscope Overtube - GI 110140-2
NEPTUNE MEDICAL INC.
2021-06-07
Pathfinder® Endoscope Overtube - GI 065140-2
NEPTUNE MEDICAL INC.
2021-06-07
Pathfinder - GI 085140-2
NEPTUNE MEDICAL INC.
2021-01-28
Pathfinder® - GI 085140
NEPTUNE MEDICAL INC.
2020-07-20