What is FDA product code KTI?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Ear Nose & Throat › SurgicalBronchoscope Accessory

Disposable Grasping Forceps(Parallel Basket TYPE,3Fr.)

Name: Disposable Grasping Forceps(Parallel Basket TYPE,3Fr.)
Brand: Disposable Grasping Forceps(Parallel Basket TYPE,3Fr.)

2 catalogue numbers from FG-51D, listed by Olympus Medical Systems Corp., Japan, under Bronchoscope Accessory. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

2catalogue numbers in this listing

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KTI
Manufacturer	City	Province	Registered as	Device types
Smartdata Suzhou Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	11
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Dongguan TT Medical, Inc.	Dongguan	Guangdong	Manufacturer	4

Record

Regulatory record for Disposable Grasping Forceps(Parallel Basket TYPE,3Fr.)
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	KTI
Device type	Bronchoscope Accessory
Device class	Class 2
Regulation	21 CFR 874.4680
Establishment	Specification developer, Manufacturer, Exporter
Record published	2021-12-30
Record revised	2023-01-16 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Distribution end date	2022-08-10

Catalogue Numbers

Catalogue numbers for Disposable Grasping Forceps(Parallel Basket TYPE,3Fr.)
Catalogue number	Size	Status
FG-51D		Withdrawn
FG-55D		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bronchoscope Accessory	Richard Wolf Gmbh	42
MultiStage®	Dongguan TT Medical, Inc.	24
Elation™	Merit Medical Systems, Inc.	23
Inspira AIR	Acclarent, Inc.	14
Texas	Richard Wolf Gmbh	10
Trachealator Non-occlusive Airway Dilation Balloon	Disa Medinotec (PTY) Ltd	9
Pilling	Teleflex Medical LLC	8
CRE Pulmonary	Boston Scientific Corporation	6
Single Use Aspiration Needle	Olympus Medical Systems Corp.	5
Cook	Cook Incorporated	3
Areus(TM) Endobronchial Ultrasound Aspiration Needle	Micro-Tech (Nanjing) Co., Ltd.	3
Trident(TM) Endobronchial Ultrasound Biopsy Needle	Micro-Tech (Nanjing) Co., Ltd.	3

Showing 12 of 37. All products under Bronchoscope Accessory

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K251664	2025-07-29
K250263	2025-03-31
K190239	2019-12-10

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.