Polygon Resection Device

510(k) K182675

Polygon Resection Device is a Class II device made by Polygon Medical, Inc., cleared under FDA 510(k) K182675 on 4 Jan 2019, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K182675↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK182675	Date4 Jan 2019Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K182675

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K182675
FDA product code: HIH

Device class: Class II
Regulation: 21 CFR Part 884.1690
Advisory committee: Obstetrics/Gynecology
FDA decision: SESE Substantially Equivalent

Devices cleared under K182675

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K182675
		UDI-DI	Size and differences
Polygon 50-100 POLYGON MEDICAL, INC.	50-100	00860001020601	Outer Diameter 3 mm	On the market

Similar devices

Other devices filed under FDA product code HIH (Hysteroscope (And Accessories)).

Other devices from Polygon Medical, Inc.

Polygon 50-100

Class II