What is FDA product code EOQ?

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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).

PlanPoint · Bronchoscope (Flexible or Rigid) → Ear Nose & Throat

Name: PlanPoint
Brand: PlanPoint

21manufacturers in China registered for this device type

1catalogue number

11510(k) clearances naming this product code

6recalls on this code

Who Else Makes It

Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EOQ
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	9
Ningbo Wise Optomech Technology Corporation	Ningbo	Zhejiang	Contract manufacturer	4
Hangzhou Broncus Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	1
Tianjin Puli Ark Medical Technology Co., Ltd.	Dongli District	Tianjin	Contract manufacturer	1
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Huanyi Sterilization Technology Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	25
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Suzhou Prosteri Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Suzhou Virgil Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Anrei Medical (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	12

Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)

Record

Regulatory record for PlanPoint
Listed by	Intuitive Surgical, Inc., United States
FDA product code	EOQ
Device type	Bronchoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4680
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2019-03-21
Record revised	2026-07-28 (version 46)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date

Catalogue Numbers

Catalogue numbers for PlanPoint
Catalogue number	Size	Status
380718		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bronchoscope (Flexible Or Rigid)	Karl Storz GmbH & Co. KG	248
Pentax	Hoya Corporation	39
Biopsy Forceps	Olympus Medical Systems Corp.	31
Single-Use flexible Video Bronchoscope	Hunan Vathin Medical Instrument Co., Ltd.	27
Pilling	Teleflex Medical LLC	24
Silicone cap	Efer Endoscopy	22
Bronchoscope (Flexible Or Rigid)	Intuitive Surgical, Inc.	20
Endoso	Hunan Endoso Life Technology Co., Ltd.	20
Exalt ™	Boston Scientific Corporation	17
Grasping Forceps	Olympus Medical Systems Corp.	16
LungVision Tool	Body Vision Medical Ltd	16
Fujifilm	Fujifilm Corporation	15

Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252045	2025-09-23
K252528	2025-09-05
K242070	2024-09-24
K240135	2024-04-03
K232984	2023-12-18
K220299	2022-06-16
K212048	2021-08-26
K202370	2020-11-16
K201146	2020-06-26
K192367	2019-11-26
K182188	2019-02-14

Recalls

6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2025-12-04	Class II	Process control	Due to probe bags that may have a compromised or incomplete sterile pouch seal.	110580
2024-07-12	Class II	Under Investigation by firm	There is a potential that the robotic system’s instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient’s airways.	3 units
2021-08-06	Class II	Under Investigation by firm	Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.	1625 units	2024-05-17
2020-10-23	Class II	Device Design	The distal tip ring of the fully articulating catheter may become dislodged during the procedure.	454 catheters	2022-12-05
2020-06-10	Class II	Device Design	One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reproces	67 units
2020-06-10	Class II	Device Design	One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reproces	27 units

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.

PlanPoint