What is FDA product code PTS?

This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Gastroenterology & Urology › DiagnosticEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Single Use Grasping Forceps PGA

Name: Single use grasping forceps PGA
Brand: Single use grasping forceps PGA

The single use grasping forceps is intended to be used through working channel of endoscope to remove foreign bodies.

Registry build 21.09.26

21manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PTS
Manufacturer	City	Province	Registered as	Device types
Changzhou Jiuhong Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10
Jiangsu Power-Endo Medical Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	7
Boen Healthcare Co., Ltd.	Suzhou	Jiangsu	Specification developer	263
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Beijing Zksk Technology Co., Ltd.	Beijing	Beijing	Contract manufacturer	38
Zhejiang Chuangxiang Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Yangzhou Fartley Medical Instrument Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	24
Jiangsu Vedkang Medical Science and Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	20
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
Hangzhou AGS MedTech Co., Ltd.	Hangzhou	Zhejiang	Repacker / relabeller	19
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.	Changzhou	Jiangsu	Manufacturer	14

Showing 12 of 21. All 21 manufacturers in China registered for Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Record

Regulatory record for Single use grasping forceps PGA
Listed by	Zhuhai Pusen Medical Technology Co., Ltd., China
FDA product code	PTS
Device type	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2025-02-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 5, carton of 20

Catalogue Numbers

Catalogue numbers for Single use grasping forceps PGA
Catalogue number	Size	Status
PGA		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Hangzhou AGS MedTech Co., Ltd.	106
Zksk	Beijing Zksk Technology Co., Ltd.	72
Captura	Cook Incorporated	53
Captura Pro	Cook Incorporated	28
Alton	Alton Shanghai Medical Instruments Co Ltd	9
Centra	Us Endoscopy	4
Disposable Grasping Forceps	Jiangsu Vedkang Medical Science and Technology Co., Ltd.	4
Seplou	Seplou (Zhuhai) Co., Ltd.	3
Single Use Loop Cutter FS-410	Olympus Medical Systems Corp.	3
Anrei	Anrei Medical(HZ) Co., Ltd.	2
Histoguide wire guided forceps	Us Endoscopy	2
Cook	Cook Incorporated	2

Showing 12 of 39. All products under Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.