GYNESCOPE, SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs 01

by Illumigyn, Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number17290018240011 UDI-DI	Date20 Nov 2020Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

GUDID

Trade Name: GYNESCOPE, SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs
Generic Name: Video colposcope camera/display unit
Model / Ref / Catalog: 01, IL-100-100-000

Primary DI / UDI-DI: 17290018240011
510(k) Number: K190187
FDA Product Code: HEX
GMDN Term: Video colposcope camera/display unit

Device Class: Class II
Regulation Number: 884.1630
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

Other devices from Illumigyn, Ltd.

Gynescope single use vaginal speculume size small 60 units 01

Class II
Gynescope system, cart 01

Class II
Gynescope single use vaginal speculum size large 60 units 01

Class II
Gynescope Image acquistion system 01

Class II
Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each 01

Class II
Gynescope, console system 01

Class II

See all devices from Illumigyn, Ltd. →

Properties

Prescription Use
Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Expiration Date: No