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Polygon 50-100

by Polygon Medical, Inc.

Polygon 50-100 is a Class II device made by Polygon Medical, Inc., cleared under FDA 510(k) K182675 on 4 Jan 2019 and listed in FDA GUDID since 3 Jun 2019 (UDI-DI 00860001020601), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

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 submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860001020601 UDI-DI Date3 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182675 Date4 Jan 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182675 decided 4 Jan 2019 Active
  • FDA GUDID UDI-DI 00860001020601 listed 3 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182675
  2. Listed FDA GUDID 00860001020601

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Polygon
Generic name
Tissue morcellation system
Model / reference
50-100
Primary DI / UDI-DI
00860001020601
510(k) Number
FDA product code
HIH
GMDN term
Tissue morcellation system
Device class
Class II
Regulation number
884.1690
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 3 Millimeter

Related devices

Category: Tissue morcellation system

Similar devices in this category

Other devices filed under Tissue morcellation system.

Other devices from Polygon Medical, Inc.

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)