InSure FIT 01

by Enterix Inc. 8 variants

InSure FIT 01 (16800) is a Class II device made by Enterix Inc., cleared under FDA 510(k) K101831 on 1 Oct 2010 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00850093003033), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850093003033 UDI-DI	Date20 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK101831	Date1 Oct 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850093003033
FDA 510(k) database 510(k) number K101831

Across registries

2 registries list this device

FDA 510(k) K101831 decided 1 Oct 2010 Active
FDA GUDID UDI-DI 00850093003033 listed 20 Sep 2016 Listed

Timeline

2 dated events

1 Oct 2010 Cleared FDA 510(k) K101831
20 Sep 2016 Listed FDA GUDID 00850093003033

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: InSure FIT
Generic name: Faecal occult blood IVD, control
Model / Ref / Catalog: 01, 16800

Primary DI / UDI-DI: 00850093003033
510(k) Number: K101831
FDA product code: OSL
GMDN term: Faecal occult blood IVD, control

Device class: Class II
Regulation number: 864.6550
GUDID distribution status: In Commercial Distribution

Other devices from Enterix Inc.

InSure® ONE™ 01 Open recall

Class II
InSure FIT 01

Class II
InSure ONE Open recall

Class II
!nsure Fecal Occult Blood Test

Class II

See all devices from Enterix Inc. →

Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)