Inrad 991016

Inrad 991016 is a Class II device made by Inrad, cleared under FDA 510(k) K093256 on 17 Nov 2009 and listed in FDA GUDID since 1 Dec 2016 (UDI-DI 00817295020626), 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	Number00817295020626 UDI-DI	Date1 Dec 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093256	Date17 Nov 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817295020626
FDA 510(k) database 510(k) number K093256

Across registries

2 registries list this device

FDA 510(k) K093256 decided 17 Nov 2009 Active
FDA GUDID UDI-DI 00817295020626 listed 1 Dec 2016 Listed

Timeline

2 dated events

17 Nov 2009 Cleared FDA 510(k) K093256
1 Dec 2016 Listed FDA GUDID 00817295020626

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Inrad
Generic name: Side-notch biopsy gun handpiece/needle
Model / reference: 991016

Primary DI / UDI-DI: 00817295020626
510(k) Number: K093256
FDA product code: KNW
GMDN term: Side-notch biopsy gun handpiece/needle

Device class: Class II
Regulation number: 876.1075
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)